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Intraoperative local anaesthesia for paediatric postoperative oral surgery pain – a randomized controlled trial
Int. J. Oral Maxillofac. Surg. 2006; 35: 1114–1119 doi:10.1016/j.ijom.2006.07.007, available online at http://www.sciencedirect.com
Clinical Paper Oral Medicine/Therapeutics
Intraoperative local anaesthesia for paediatric postoperative oral surgery pain – a randomized controlled trial
P. Coulthard, S. Rolfe, I. C. Mackie, G. Gazal, M. Morton, D. Jackson-Leech Oral and Maxillofacial Surgery, School of Dentistry, The University of Manchester, Manchester, M15 6FH, UK
P. Coulthard, S. Rolfe, I. C. Mackie, G. Gazal, M. Morton, D. Jackson-Leech: Intraoperative local anaesthesia for paediatric postoperative oral surgery pain – a randomized controlled trial. Int. J. Oral Maxillofac. Surg. 2006; 35: 1114–1119. # 2006 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved. Abstract. The aim of this study was to improve the pain experience for children following oral surgery under general anaesthesia. To this end, the efficacy and safety of intraoperative local anaesthetic (2% lidocaine with 1:200,000 epinephrine) for postoperative pain control was investigated. In a randomized controlled trial, 142 patients aged 12 years or less, who were scheduled for dental extractions under general anaesthesia, received local anaesthesia or saline intraoral injection after induction of anaesthesia. There was statistically no significant difference between groups for pain scores recorded preoperatively, on waking, at 30 min, at 24 h, or for distress scores recorded preoperatively, on waking and at 30 min. ‘Severe’ pain scores were recorded for 13% of treatment and 12% of control patients and ‘very severe’ for 13% of treatment and 10% of control patients on waking. These rates were similar at 30 min but reduced at 24 h. Lip/cheek biting injuries occurred in one control and three treatment patients. Intraoperative local anaesthesia has been found to be effective for pain control following a range of other surgical procedures, but we did not find it to be effective in reducing postoperative pain or distress in children after oral surgery. Reasons may include unfamiliarity with altered orofacial sensation.
Postoperative pain management in children has been a subject of increasing interest during the last decade but is still recognised as being frequently suboptimal9,21. Historically, infiltration with local anaesthetic for postoperative pain relief has not been used for children during general anaesthetic dental procedures 0901-5027/121114 + 06 $30.00/0
and is still not always part of routine clinical practice. In a previous study, two of the authors of this study found no evidence of reduced postoperative pain when 0.25% bupivicaine was applied topically to sockets immediately on extraction of teeth under general anaesthesia7. Local anaesthesia, however, has been used for
Keywords: oral surgery; postoperative pain; randomized controlled trial; paediatric; local anaesthetic; lidocaine. Accepted for publication 5 July 2006 Available online 2 October 2006
other surgical procedures with good effect3,25. Over the last decade, the practice of using general anaesthesia for dental extractions has been scrutinized in the UK by the dental and anaesthetic professionals, especially in relation to safety. The Royal College of Surgeons of England22 and the British Government5
# 2006 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
Paediatric postoperative oral surgery pain have published several reports, and the General Dental Council8,16 has revised its guidance to the dental profession on several occasions with the intention of improving safety and reducing the number of general anaesthetic procedures in dental treatment. For certain patients, especially young children, there will always be a need to have dental extractions carried out under general anaesthesia. Little work has been carried out to investigate morbidity in children requiring general anaesthetic dental extractions. One study has reported morbidity to be common with distressing consequences for the young patients and their carers2. Distress was noted in 26 (33%) patients during recovery. Continued crying was reported for 24 (39%) pateints during the journey home and for 23 (37%) patients once home had been reached. Other symptoms included nausea, vomiting and prolonged bleeding. Six reported psychological trauma 1 month after: three had nightmares, two had continuing bad memories and one was depressed for several days. The overall aim of this study was to investigate whether the general anaesthetic extraction experience could be improved for children by reducing the postoperative pain experienced. Our hypothesis was that by using local anaesthetic during the general anaesthetic children would wake up pain free and remain so for several hours. A potential problem also to be assessed was that children might lip or cheek bite the anaesthetized area causing a traumatic injury. Nerve blockade has not been shown to have a significant advantage over infiltration with local anaesthetic in other types of surgery11, and so it was elected to use infiltration rather than inferior alveolar nerve block for lower tooth extractions to avoid altering tongue sensation. The efficacy and safety
of local anaesthetic using 2% lidocaine with 1:200,000 epinephrine for postoperative pain control in paediatric patients undergoing oral surgery under general anaesthesia was investigated. The results of measurement of the primary efficacy variables of postoperative pain and postoperative emotional distress, and primary safety variable of frequency of any lip or cheek biting are reported. Methods Screening
This study was approved by the Central Manchester and Manchester Children’s University Hospitals NHS Trust Research Ethics Committee. Parents/guardians of patients who satisfied all eligibility criteria were approached on attendance for the day’s surgical schedule and asked if they were willing to allow their child to participate and provide informed consent on behalf of their child, who was then recruited into the study. A study information sheet was provided. Competent children were also invited to agree and were provided with an information sheet especially written for children. If the parent/guardian agreed but the child did not agree, then the child was not included into the study. Study inclusion critieria were as follows: male or female patient aged 4–12 years scheduled for extraction of 1–10 teeth, ASA physical status I or II and with a parent/guardian who was able to understand and co-operate with the requirements of the protocol and was able and willing to provide appropriate written informed consent. Patients were excluded from participating in the study if they had a known hypersensitivity or allergy to lidocaine or acetaminophen. The patient’s initials and date of birth were recorded for identification purposes. Demographic
Fig. 1. Five-face scale for pain intensity measurement.
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details, teeth to be removed and previous general and local anaesthetic experiences were recorded. Treatment
A preoperative pain measure using a fiveface scale (Fig. 1) was completed by the child, and a preoperative evaluation of distress was made by the research nurse using a five-category scale of behavioural distress (asleep, drowsy, placid, agitated and distressed). All patients received 15 mg kg 1 acetaminophen elixir preoperatively and EMLA1 (eutectic mixture of local anaesthetics, 2.5% lidocaine and 2.5% prilocaine) topical paste on the dorsum of both hands about 1 h preoperatively, as is usual clinical practice, and the time to surgery was noted. A computer-generated randomization code was held by the research secretary, and group allocation was concealed using opaque sealed envelopes that were opened on intravenous induction of general anaesthesia by the surgeon. The appropriate drug, 2 ml of 2% lidocaine with 1:200,000 epinephrine or 2 ml of 0.9% sodium chloride as placebo, was administered by buccal infiltration injection adjacent to the teeth to be removed. The group allocation envelope was re-sealed and attached to the data collection form for the child. The envelope was not re-opened until completion of the study. General anaesthetic induction was with propofol, and nitrous oxide, oxygen and sevoflurane via a laryngeal mask were used for maintenance. Following tooth removal with elevators and forceps, the child was transferred by operating trolley to the recovery room adjacent to the operating theatre. Postoperative pain and distress were measured on waking from the anaesthesia by the research nurse, using the appropriate
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scales. Further postoperative pain and distress measurements were recorded at 30 min by the nurse, and a pain score was also recorded by the child. The research nurse did not enter the operating theatre and was blind to the group allocation. All patients/guardians were given acetaminophen elixir to take home with appropriate dosing information. They were advised to administer the acetaminophen to their child as required for pain. Patients were discharged home when considered fit for discharge with a parent/guardian shortly after the 30-min measurements. Parents were advised to observe their child for lip or cheek biting injuries and encourage them to stop should this be observed. Fig. 2. Bar graph showing mean pain score for local anaesthetic and placebo groups. Follow-up
The parent/guardian was contacted by telephone 24 h later and asked for a rating of overall pain experienced by their child. They had been provided with a five-face scale and instructions for its use. Parents/ guardians were also asked if any lip or cheek biting injury had occurred, and if it had, they were offered an outpatient appointment for review. Such injuries usually do heal spontaneously within a few days, but reassurance of the parent/ guardian is important. If no injury was reported, then no further outpatient appointment was arranged. In addition, parents/guardians were asked if their child had required any acetaminophen. An information sheet describing the study was given to the parent/guardian on discharge of their child so that it could be shown to the general dental practitioner or general medical practitioner should he or she be involved in providing care for the child within 1 week of the dental treatment. Statistical analysis
A study by WRIGHT25 investigating local anaesthetic for pain control after appendectomy in children was used for the sample size calculation. It was determined that a sample of 64 in each group would have 80% power to detect a difference in means of 2 (the difference between the local anaesthetic group mean of 5 and the placebo group mean of 7) assuming that the common standard deviation was 4 and using a two-group t-test with a 0.05 twosided significance level (n Query Adviser 2.0, 1997). It was anticipated that up to 142 patients should be enrolled to provide 128 evaluable patients, an evaluable patient for the primary efficacy analysis
being a patient satisfying the eligibility criteria for entry into the study and missing no clinical assessments. Comparisons between the test and control groups were made using an independent sample t-test at the 0.05 level of significance, and comparisons of the same group with time were made using the paired sample t-test. Results
One hundred and forty-two children were recruited to the study and randomly allocated to one of the two groups. Data were incomplete for three children (one in the local anaesthetic group and two in the placebo group), providing evaluable data for 70 children in the local anaesthetic group and 69 in the placebo group (n = 139). There was no significant difference between groups at baseline with respect to age (median 6 years), sex (73 males, 66 females), body weight (mean 22.5 kg, SD 6.9), number of teeth extracted (mean 5.8, SD 2.6), reason for extraction, previous general and local
anaesthesia experience, time from preoperative acetaminophen to surgery (mean 116 min, SD 30.7) or preoperative pain and distress scores. The most common reason for dental extraction was caries (86, 61.9% patients). Other reasons included acute dental abscess (48, 34.5% patients) and extraction as part of orthodontic treatment (5, 3.6% patients). There was no statistically significant difference between the mean pain scores for the local anaesthetic and placebo group preoperatively, on waking from the general anaesthesia, at 30 min postoperatively or at 24 h (Fig. 2). There were significant increases in mean pain scores when comparing the preoperative scores with those on waking at 30 min and at 24 h postoperatively (Table 1). Pain scores of ‘severe’ were recorded for nine (12.9%) local anaesthetic and eight (11.6%) placebo patients, and ‘very severe’ for nine (12.9%) local anaesthetic and seven (10.1%) placebo patients on waking. At 30 min, pain scores of ‘severe’ were recorded for nine (12.9%) local anaesthetic and eight (11.6%) placebo
Table 1. Comparison between mean preoperative pain scores and scores on waking, and 30 min and 24 h postoperatively for children in the local anaesthetic and placebo groups Mean (SD) Local anaesthetic
Placebo
Paired t-value (DF)
P-value
Preoperative On waking Preoperative 30 min postoperative Preoperative 24 h postoperative
0.06 1.45 0.06 1.74 0.06 0.69
(0.24) (1.38) (0.23) (1.44) (0.23) (1.10)
8.28 (68)
<0.001
9.80 (69)
<0.001
4.7 (69)
<0.001
Preoperative On waking Preoperative 30 min postoperative Preoperative 24 h postoperative
0.10 1.37 0.10 1.70 0.10 0.75
(0.43) (1.32) (0.43) (1.32) (0.43) (1.23)
8.48 (67)
<0.001
10.56 (68)
<0.001
4.1 (67)
<0.001
Paediatric postoperative oral surgery pain Table 2. Comparison between mean pain scores for patients aged 4–6 years and 7–12 years, preoperatively, on waking and 30 min postoperatively Age (years)
Mean (SD)
t-test (DF)
P-value
Preoperatively
4–6 7–12
0.09 (0.4) 0.04 (0.2)
0.40 (139)
0.40
On waking
4–6 7–12
1.51 (1.5) 1.19 (1.0)
1.32 (135)
0.19
30 min postoperatively
4–6 7–12
1.86 (1.6) 1.73 (1.4)
0.49 (136)
0.63
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at 30 min postoperatively (Fig. 3). The increase from preoperative distress to on waking distress was not statistically significant, but the increase at 30 min was statistically significant for both groups (Table 3). Children aged 4–6 years reported significantly higher distress scores than children aged 7–12 years on recovery and at 30 min (Table 4). There was also significantly higher distress when 7–10 teeth were extracted when compared to 1–6 teeth at 30 min postoperatively (P = 0.007). Four patients were reported by their parent/guardian to have a lip/cheek biting injury at 24 h after surgery. Three of these patients were in the local anaesthetic group and one was in the placebo group. All four patients were followed up by review at an outpatient clinic, and all lesions healed spontaneously within a few days. Discussion
Fig. 3. Bar graph showing mean distress score for local anaesthetic and placebo groups.
patients, and ‘very severe’ for 13 (18.6%) local anaesthetic and 18 (26.1%) placebo patients. At 24 h parents/guardians provided much lower overall pain intensity scores with only two (2.9%) local anaesthetic and 0 (0%) placebo patients recording ‘severe’, and 0 (0%) local anaesthetic and one (1.5%) placebo patient recording ‘very severe’. There was no significant difference in mean pain scores for children aged 4–6 years and those aged 7–12 years preoperatively, on recovery or at 30 min (Table 2). Previous general anaesthesia was experienced by 13 (18.6%) local anaesthetic and 18 (26.1%) placebo group patients. Local anaesthesia had been experienced by two (2.9%) local anaesthetic and five (7.2%) placebo groups patients. Children who had 7–12 teeth extracted had significantly greater pain scores on recovery and at 30 min than those having 1–6 teeth extracted (P = 0.03; P = 0.045). There was a high correlation between the pain scores reported by the research nurse and those reported by the patients using the fiveface scale (Pearson’s correlation coefficient (0.86) was significant at the 0.01 level). Acetaminophen elixir was provided at home over the first 24 h after surgery by a parent/guardian for 58 (82.9%) local
anaesthetic group children and for 60 (86.9%) placebo group children. This difference was not statistically significant. There were no statistically significant differences between the mean distress scores for the local anaesthetic and placebo group preoperatively, on waking and
A survey of anaesthetists providing anaesthesia for dental procedures in children under 10 years of age in Scotland suggested that the majority asked their dental colleagues to inject local anaesthetic, using lidocaine with epinephrine or prilocaine with felypressin for postoperative pain control15. In this study, no statistically significant difference was demonstrated in pain or distress scores between children receiving 2% lidocaine with 1:200,000 epinephrine or 0.9% sodium chloride as placebo administered by buccal infiltration injection adjacent to the teeth to be removed. Similarly, there was no significant difference in postoperative requirement for the
Table 3. Comparison between mean preoperative distress scores and scores on waking and 30 min postoperatively for children in the local anaesthetic and placebo groups Mean (SD) Local anaesthetic
Placebo
Paired t-value (DF)
P-value
Preoperative On waking Preoperative 30 min postoperative
2.07 2.24 2.08 2.57
(0.27) (0.87) (0.28) (0.83)
1.50 (67)
0.14
4.11 (59)
<0.001
Preoperative On waking Preoperative 30 min postoperative
2.12 2.20 2.13 2.42
(0.45) (0.85) (0.46) (0.74)
0.70 (65)
0.49
2.70 (61)
0.007
Table 4. Comparison between mean distress scores for patients aged 4–6 years and 7–12 years, preoperatively, on waking and 30 min postoperatively Mean (SD)
t-test (DF)
P-value
Preoperatively
Age (years) 4–6 7–12
2.1 (0.4) 2.0 (0.5)
1.60 (136)
0.11
On waking
4–6 7–12
2.6 (0.9) 1.9 (0.7)
2.71 (131)
30 min postoperatively
4–6 7–12
2.6 (0.8) 2.3 (0.6)
2.17 (121)
.008 0.03
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administration of acetaminophen elixir between the two patient groups. These are disappointing findings, particularly as significant pain and distress were identified, and the removal of teeth is a common oral surgery procedure and one of the most common surgical procedures that children undergo in the UK. Similar studies investigating other types of surgery, including tonsilletomy19, orchidopexy13, hypospadias repair3, appendicectomy25 and femoral nailing10, have demonstrated significant reductions in postoperative pain with the use of intraoperative local anaesthesia. Interestingly, in another study when ropivacaine with epinephrine was administered immediately after tonsillectomy the authors were unable to demonstrate any reduction in postoperative pain20. The intraoral infiltration of local anaesthesia causes profound alteration of orofacial sensation particularly affecting the lips and cheek. Patients are often less aware of altered sensation when local anaesthesia is used on areas of the body where the skin is less highly innervated. Most children requiring general rather than local anaesthesia for dental extractions do so because of anxiety, behavioural difficulties or because multiple extractions are required. Many of these children do not attend regularly for dental treatment and may have had no previous experience of the altered sensation associated with a dental local anaesthetic injection. In our study, only 5% of children had previous experience of dental local anaesthetic. Perhaps the altered sensation may have caused distress in patients waking from anaesthesia. There were a number of children who reported pain preoperatively in both groups. This is to be expected as the majority were having teeth removed because of dental caries and acute dental abscesses, and both of these conditions can cause pain. Similarly, distress was recorded preoperatively. This may have been associated with pain or anxiety about the prospect of the surgical procedure or general anaesthesia, or the novel environment. There were significant increases in mean pain scores when comparing the preoperative scores with those on waking, at 30 min postoperatively and at 24 h. Pain scores of ‘severe’ were reported by 12.9% of the local anaesthesia and 11.6% of the placebo group, and ‘very severe’ by 18.6% of the local anaesthesia and 26.1% of the placebo group at 30 min. Children that had 7–10 teeth extracted had significantly greater pain scores on recovery and at 30 min than those having 1–6 teeth extracted. It was disappointing and a mat-
ter of concern to find such a large number of high pain scores, particularly as both groups received both preoperative and postoperative acetaminophen elixir. Other researchers have also noted significant pain after paediatric dental procedures despite preoperative acetaminophen21. The five-face pain score was used to obtain a pain measurement from the child preoperatively and at 30 min postoperatively. A research nurse used the same scale to provide a measure of pain for the child on waking from anaesthesia, when it was thought that the child might be too disorientated to provide a meaningful score for themselves, and at 30 min. All distress scores were undertaken by the research nurse. Pain scores were recorded by the parent at 24 h. Distress and pain may not be easy to distinguish in young patients, and there has been concern that paediatric nurse assessment of pain may be based upon overt distress17. There was good correlation of the scores recorded by the independent research nurse and the child’s self-report of pain as has been shown previously24. Others have suggested that there can be poor agreement between pain ratings by children, parents and practitioners, and there is a lack of clarity about which assessment best approximates the true degree of pain the child is experiencing23. The increase from preoperative distress to on-waking distress was not statistically significant but the increase at 30 min was statistically significant for both groups. The distress at 30 min may therefore have been associated with pain rather than distress because of disorientation on recovery from general anaesthesia. This is supported by the finding that significantly higher distress was reported when 7–10 teeth were extracted when compared with extractions of 1–6 teeth at 30 min postoperatively. Certainly pain has been reported by others as the most significant factor in promoting emotional distress18. Another possible explanation for the postoperative distress could be the bleeding following teeth extractions. Other studies6,12 have reported distress related to bleeding in children who had dental care under general anaesthetic with concern caused by the taste of blood in the mouth. It is important to improve the postoperative experience as distress can lead to behavioural disorders on returning home and a negative attitude to future dental procedures1. More distress was recorded for younger patients than older ones on recovery and at 30 min although there was no significant difference with respect to age in pain scores recorded. This may be because younger children have more limited cognition. It
has been reported in a study of laceration closure that children who exhibited relinquished-control coping experienced more pain during the procedure14. The administration of a range of coping behaviours and improvement in parental support could be useful in reducing pain and distress in children. Young children tend to depend on their parents for support in a fearful situation rather than having their own coping mechanisms. A study comparing the efficacy of parents and nurses in reducing distress associated with immunization pain, however, found that, in general, the nurses’ behaviour was associated with child coping and parents’ behaviour with child distress4. The same study investigated training of the children to cope but found that whilst children demonstrated understanding of the training they did not use these coping skills during the procedure. This area requires further investigation. Four patients were reported by their parent/guardian to have a lip/cheek biting injury at 24 h after surgery. Three of these patients were in the local anaesthetic group and one was in the placebo group. These injuries can cause alarm in the parents and child because of their sinister appearance. It was interesting to find that one patient receiving placebo inflicted such an injury. As few children suffered injury, it is suggested that intraoperative local anaesthesia is not contraindicated on the basis of safety although its use cannot be recommended from this study as no pain-control benefit was demonstrated. The results of this study suggest that the management of pain after oral surgery in paediatric patients presents its own particular challenges, and highlight the need to find alternative strategies to improve the quality of the experience for the child. Surely pain relief is a fundamental human right in addition to being a good clinical and ethical practice. References 1. Al-Bahlani S, Sherriff A, Crawford PJ. Tooth extraction, bleeding and pain control. J R Coll Surg Edinb 2001: 46: 261–264. 2. Bridgman CM, Ashby D, Holloway PJ. An investigation of the effects on children of tooth extraction under general anaesthesia in general dental practice. J Dent 1999: 186: 245–247. 3. Chhibber AK, Perkins FM, Rabinowitz R, Vogt AN, Hulbert WC. Penile block timing for postoperative analgesia of hypospadias repair in children. J Urol 1997: 158: 1156–1159. 4. Cohen LL, Bernard RS, Greco LA, McClellan CB. A child-focused intervention for coping with procedural pain:
Paediatric postoperative oral surgery pain
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are parent and nurse coaches necessary? J Pediatr Psychol 2002: 27: 749–757. Department of Health. General anaesthesia, sedation and resuscitation in dentistry: Report of an expert working party. London: HMSO 1991. Enever GR, Nunn JH, Sheehan JK. A comparison of post-operative morbidity following outpatient dental care under general anaesthesia in paediatric patients with and without disabilities. Int J Paediatr Dent 2000: 10: 120–125. Gazal G, Bowman R, Worthington HV, Mackie I. A double-blind randomized controlled trial investigating the effectiveness of topical bupivacaine in reducing distress in children following extractions under general anaesthesia. Int J Paediatr Dent 2004: 14: 425–431. General Dental Council. Report from the general anaesthesia and sedation review group. London: GDC 1996. Goddard JM, Pickup SE. Postoperative pain in children. Anaesthesia 1996: 51: 588–590. Herrera JA, Wall EJ, Foad SL. Hematoma block reduces narcotic pain medication after femoral elastic nailing in children. J Pediatr Orthop 2004: 24: 254–256. Isaac LA, McEwan J, Hayes JA, Crawford MW. A pilot study of the rectus sheath block for pain control after umbilical hernia repair. Paediatr Anaesth 2006: 16: 406–409. Jurgens S, Warwick RS, Inglehearn PJ, Gooneratne DS. Pain relief for paediatric dental chair anaesthesia: a current
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practice in a community dental clinic. Int J Paediatr Dent 2003: 13: 93–97. Lafferty PM, Gordon NH, Winning TJ. A comparison of postoperative pain relief techniques in orchidopexy. Ann R Coll Surg Engl 1990: 72: 7–8. Langer DA, Chen E, Luhmann JD. Attributions and coping in children’s pain experiences. J Pediatr Psychol 2005: 30: 615–622. MacMillan CS, Wildsmith JA. A survey of paediatric dental anaesthesia in Scotland. Anaesthesia 2000: 55: 581– 586. Maintaining standards – guidance to dentists on professional and personal conduct. London: General Dental Council, November, 1997 (Revised November 1998 and May 1999). Manne SL, Jacobsen PB, Redd WH. Assessment of acute pediatric pain: do child self-report, parent ratings, and nurse ratings measure the same phenomenon? Pain 1992: 48: 45–52. Mather L, Mackie L. The incidence of postoperative pain in children. Pain 1983: 15: 171–182. Naja MZ, El-Rajab M, Kabalan W, Ziade MF, Al-Tannir MA. Pre-incisional infiltration for pediatric tonsillectomy: A randomized double-blind clinical trial. Int J Pediatr Otorhinolaryngol 2005: 69: 1333–1341. Park AH, Pappas AL, Fluder E, Creech S, Lugo RA, Hotaling A. Effect of perioperative administration of ropivacaine with epinephrine on postoperative pediatric adenotonsillectomy
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recovery. Arch Otolaryngol Head Neck Surg 2004: 130: 459–464. Primosch RE, Antony SJ, Courts FJ. The efficacy of preoperative analgesic administration for postoperative pain management of pediatric dental patients. Anesth Pain Control Dent 1993: 2: 102– 106. Royal College of Surgeons of England. Guidelines for sedation by non-anaesthetists. Report of a working party. London: RCS 1993. Singer AJ, Gulla J, Thode Jr HC. Parents and practitioners are poor judges of young children’s pain severity. Acad Emerg Med 2002: 9: 609–612. Versloot J, Veerkamp JS, Hoogstraten J. Assessment of pain by the child, dentist, and independent observers. Pediatr Dent 2004: 26: 445–449. Wright JE. Controlled trial of wound infiltration with bupivacaine for postoperative pain relief after appendicectomy in children. Br J Surg 1993: 80: 110–111.
Address: Paul Coulthard School of Dentistry The University of Manchester Higher Cambridge Street Manchester M15 6FH UK Tel: +44 161 275 6650 Fax: +44 161 275 6631 E-mail: [email protected]
Clinical Paper Oral Medicine/Therapeutics
Intraoperative local anaesthesia for paediatric postoperative oral surgery pain – a randomized controlled trial
P. Coulthard, S. Rolfe, I. C. Mackie, G. Gazal, M. Morton, D. Jackson-Leech Oral and Maxillofacial Surgery, School of Dentistry, The University of Manchester, Manchester, M15 6FH, UK
P. Coulthard, S. Rolfe, I. C. Mackie, G. Gazal, M. Morton, D. Jackson-Leech: Intraoperative local anaesthesia for paediatric postoperative oral surgery pain – a randomized controlled trial. Int. J. Oral Maxillofac. Surg. 2006; 35: 1114–1119. # 2006 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved. Abstract. The aim of this study was to improve the pain experience for children following oral surgery under general anaesthesia. To this end, the efficacy and safety of intraoperative local anaesthetic (2% lidocaine with 1:200,000 epinephrine) for postoperative pain control was investigated. In a randomized controlled trial, 142 patients aged 12 years or less, who were scheduled for dental extractions under general anaesthesia, received local anaesthesia or saline intraoral injection after induction of anaesthesia. There was statistically no significant difference between groups for pain scores recorded preoperatively, on waking, at 30 min, at 24 h, or for distress scores recorded preoperatively, on waking and at 30 min. ‘Severe’ pain scores were recorded for 13% of treatment and 12% of control patients and ‘very severe’ for 13% of treatment and 10% of control patients on waking. These rates were similar at 30 min but reduced at 24 h. Lip/cheek biting injuries occurred in one control and three treatment patients. Intraoperative local anaesthesia has been found to be effective for pain control following a range of other surgical procedures, but we did not find it to be effective in reducing postoperative pain or distress in children after oral surgery. Reasons may include unfamiliarity with altered orofacial sensation.
Postoperative pain management in children has been a subject of increasing interest during the last decade but is still recognised as being frequently suboptimal9,21. Historically, infiltration with local anaesthetic for postoperative pain relief has not been used for children during general anaesthetic dental procedures 0901-5027/121114 + 06 $30.00/0
and is still not always part of routine clinical practice. In a previous study, two of the authors of this study found no evidence of reduced postoperative pain when 0.25% bupivicaine was applied topically to sockets immediately on extraction of teeth under general anaesthesia7. Local anaesthesia, however, has been used for
Keywords: oral surgery; postoperative pain; randomized controlled trial; paediatric; local anaesthetic; lidocaine. Accepted for publication 5 July 2006 Available online 2 October 2006
other surgical procedures with good effect3,25. Over the last decade, the practice of using general anaesthesia for dental extractions has been scrutinized in the UK by the dental and anaesthetic professionals, especially in relation to safety. The Royal College of Surgeons of England22 and the British Government5
# 2006 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
Paediatric postoperative oral surgery pain have published several reports, and the General Dental Council8,16 has revised its guidance to the dental profession on several occasions with the intention of improving safety and reducing the number of general anaesthetic procedures in dental treatment. For certain patients, especially young children, there will always be a need to have dental extractions carried out under general anaesthesia. Little work has been carried out to investigate morbidity in children requiring general anaesthetic dental extractions. One study has reported morbidity to be common with distressing consequences for the young patients and their carers2. Distress was noted in 26 (33%) patients during recovery. Continued crying was reported for 24 (39%) pateints during the journey home and for 23 (37%) patients once home had been reached. Other symptoms included nausea, vomiting and prolonged bleeding. Six reported psychological trauma 1 month after: three had nightmares, two had continuing bad memories and one was depressed for several days. The overall aim of this study was to investigate whether the general anaesthetic extraction experience could be improved for children by reducing the postoperative pain experienced. Our hypothesis was that by using local anaesthetic during the general anaesthetic children would wake up pain free and remain so for several hours. A potential problem also to be assessed was that children might lip or cheek bite the anaesthetized area causing a traumatic injury. Nerve blockade has not been shown to have a significant advantage over infiltration with local anaesthetic in other types of surgery11, and so it was elected to use infiltration rather than inferior alveolar nerve block for lower tooth extractions to avoid altering tongue sensation. The efficacy and safety
of local anaesthetic using 2% lidocaine with 1:200,000 epinephrine for postoperative pain control in paediatric patients undergoing oral surgery under general anaesthesia was investigated. The results of measurement of the primary efficacy variables of postoperative pain and postoperative emotional distress, and primary safety variable of frequency of any lip or cheek biting are reported. Methods Screening
This study was approved by the Central Manchester and Manchester Children’s University Hospitals NHS Trust Research Ethics Committee. Parents/guardians of patients who satisfied all eligibility criteria were approached on attendance for the day’s surgical schedule and asked if they were willing to allow their child to participate and provide informed consent on behalf of their child, who was then recruited into the study. A study information sheet was provided. Competent children were also invited to agree and were provided with an information sheet especially written for children. If the parent/guardian agreed but the child did not agree, then the child was not included into the study. Study inclusion critieria were as follows: male or female patient aged 4–12 years scheduled for extraction of 1–10 teeth, ASA physical status I or II and with a parent/guardian who was able to understand and co-operate with the requirements of the protocol and was able and willing to provide appropriate written informed consent. Patients were excluded from participating in the study if they had a known hypersensitivity or allergy to lidocaine or acetaminophen. The patient’s initials and date of birth were recorded for identification purposes. Demographic
Fig. 1. Five-face scale for pain intensity measurement.
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details, teeth to be removed and previous general and local anaesthetic experiences were recorded. Treatment
A preoperative pain measure using a fiveface scale (Fig. 1) was completed by the child, and a preoperative evaluation of distress was made by the research nurse using a five-category scale of behavioural distress (asleep, drowsy, placid, agitated and distressed). All patients received 15 mg kg 1 acetaminophen elixir preoperatively and EMLA1 (eutectic mixture of local anaesthetics, 2.5% lidocaine and 2.5% prilocaine) topical paste on the dorsum of both hands about 1 h preoperatively, as is usual clinical practice, and the time to surgery was noted. A computer-generated randomization code was held by the research secretary, and group allocation was concealed using opaque sealed envelopes that were opened on intravenous induction of general anaesthesia by the surgeon. The appropriate drug, 2 ml of 2% lidocaine with 1:200,000 epinephrine or 2 ml of 0.9% sodium chloride as placebo, was administered by buccal infiltration injection adjacent to the teeth to be removed. The group allocation envelope was re-sealed and attached to the data collection form for the child. The envelope was not re-opened until completion of the study. General anaesthetic induction was with propofol, and nitrous oxide, oxygen and sevoflurane via a laryngeal mask were used for maintenance. Following tooth removal with elevators and forceps, the child was transferred by operating trolley to the recovery room adjacent to the operating theatre. Postoperative pain and distress were measured on waking from the anaesthesia by the research nurse, using the appropriate
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scales. Further postoperative pain and distress measurements were recorded at 30 min by the nurse, and a pain score was also recorded by the child. The research nurse did not enter the operating theatre and was blind to the group allocation. All patients/guardians were given acetaminophen elixir to take home with appropriate dosing information. They were advised to administer the acetaminophen to their child as required for pain. Patients were discharged home when considered fit for discharge with a parent/guardian shortly after the 30-min measurements. Parents were advised to observe their child for lip or cheek biting injuries and encourage them to stop should this be observed. Fig. 2. Bar graph showing mean pain score for local anaesthetic and placebo groups. Follow-up
The parent/guardian was contacted by telephone 24 h later and asked for a rating of overall pain experienced by their child. They had been provided with a five-face scale and instructions for its use. Parents/ guardians were also asked if any lip or cheek biting injury had occurred, and if it had, they were offered an outpatient appointment for review. Such injuries usually do heal spontaneously within a few days, but reassurance of the parent/ guardian is important. If no injury was reported, then no further outpatient appointment was arranged. In addition, parents/guardians were asked if their child had required any acetaminophen. An information sheet describing the study was given to the parent/guardian on discharge of their child so that it could be shown to the general dental practitioner or general medical practitioner should he or she be involved in providing care for the child within 1 week of the dental treatment. Statistical analysis
A study by WRIGHT25 investigating local anaesthetic for pain control after appendectomy in children was used for the sample size calculation. It was determined that a sample of 64 in each group would have 80% power to detect a difference in means of 2 (the difference between the local anaesthetic group mean of 5 and the placebo group mean of 7) assuming that the common standard deviation was 4 and using a two-group t-test with a 0.05 twosided significance level (n Query Adviser 2.0, 1997). It was anticipated that up to 142 patients should be enrolled to provide 128 evaluable patients, an evaluable patient for the primary efficacy analysis
being a patient satisfying the eligibility criteria for entry into the study and missing no clinical assessments. Comparisons between the test and control groups were made using an independent sample t-test at the 0.05 level of significance, and comparisons of the same group with time were made using the paired sample t-test. Results
One hundred and forty-two children were recruited to the study and randomly allocated to one of the two groups. Data were incomplete for three children (one in the local anaesthetic group and two in the placebo group), providing evaluable data for 70 children in the local anaesthetic group and 69 in the placebo group (n = 139). There was no significant difference between groups at baseline with respect to age (median 6 years), sex (73 males, 66 females), body weight (mean 22.5 kg, SD 6.9), number of teeth extracted (mean 5.8, SD 2.6), reason for extraction, previous general and local
anaesthesia experience, time from preoperative acetaminophen to surgery (mean 116 min, SD 30.7) or preoperative pain and distress scores. The most common reason for dental extraction was caries (86, 61.9% patients). Other reasons included acute dental abscess (48, 34.5% patients) and extraction as part of orthodontic treatment (5, 3.6% patients). There was no statistically significant difference between the mean pain scores for the local anaesthetic and placebo group preoperatively, on waking from the general anaesthesia, at 30 min postoperatively or at 24 h (Fig. 2). There were significant increases in mean pain scores when comparing the preoperative scores with those on waking at 30 min and at 24 h postoperatively (Table 1). Pain scores of ‘severe’ were recorded for nine (12.9%) local anaesthetic and eight (11.6%) placebo patients, and ‘very severe’ for nine (12.9%) local anaesthetic and seven (10.1%) placebo patients on waking. At 30 min, pain scores of ‘severe’ were recorded for nine (12.9%) local anaesthetic and eight (11.6%) placebo
Table 1. Comparison between mean preoperative pain scores and scores on waking, and 30 min and 24 h postoperatively for children in the local anaesthetic and placebo groups Mean (SD) Local anaesthetic
Placebo
Paired t-value (DF)
P-value
Preoperative On waking Preoperative 30 min postoperative Preoperative 24 h postoperative
0.06 1.45 0.06 1.74 0.06 0.69
(0.24) (1.38) (0.23) (1.44) (0.23) (1.10)
8.28 (68)
<0.001
9.80 (69)
<0.001
4.7 (69)
<0.001
Preoperative On waking Preoperative 30 min postoperative Preoperative 24 h postoperative
0.10 1.37 0.10 1.70 0.10 0.75
(0.43) (1.32) (0.43) (1.32) (0.43) (1.23)
8.48 (67)
<0.001
10.56 (68)
<0.001
4.1 (67)
<0.001
Paediatric postoperative oral surgery pain Table 2. Comparison between mean pain scores for patients aged 4–6 years and 7–12 years, preoperatively, on waking and 30 min postoperatively Age (years)
Mean (SD)
t-test (DF)
P-value
Preoperatively
4–6 7–12
0.09 (0.4) 0.04 (0.2)
0.40 (139)
0.40
On waking
4–6 7–12
1.51 (1.5) 1.19 (1.0)
1.32 (135)
0.19
30 min postoperatively
4–6 7–12
1.86 (1.6) 1.73 (1.4)
0.49 (136)
0.63
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at 30 min postoperatively (Fig. 3). The increase from preoperative distress to on waking distress was not statistically significant, but the increase at 30 min was statistically significant for both groups (Table 3). Children aged 4–6 years reported significantly higher distress scores than children aged 7–12 years on recovery and at 30 min (Table 4). There was also significantly higher distress when 7–10 teeth were extracted when compared to 1–6 teeth at 30 min postoperatively (P = 0.007). Four patients were reported by their parent/guardian to have a lip/cheek biting injury at 24 h after surgery. Three of these patients were in the local anaesthetic group and one was in the placebo group. All four patients were followed up by review at an outpatient clinic, and all lesions healed spontaneously within a few days. Discussion
Fig. 3. Bar graph showing mean distress score for local anaesthetic and placebo groups.
patients, and ‘very severe’ for 13 (18.6%) local anaesthetic and 18 (26.1%) placebo patients. At 24 h parents/guardians provided much lower overall pain intensity scores with only two (2.9%) local anaesthetic and 0 (0%) placebo patients recording ‘severe’, and 0 (0%) local anaesthetic and one (1.5%) placebo patient recording ‘very severe’. There was no significant difference in mean pain scores for children aged 4–6 years and those aged 7–12 years preoperatively, on recovery or at 30 min (Table 2). Previous general anaesthesia was experienced by 13 (18.6%) local anaesthetic and 18 (26.1%) placebo group patients. Local anaesthesia had been experienced by two (2.9%) local anaesthetic and five (7.2%) placebo groups patients. Children who had 7–12 teeth extracted had significantly greater pain scores on recovery and at 30 min than those having 1–6 teeth extracted (P = 0.03; P = 0.045). There was a high correlation between the pain scores reported by the research nurse and those reported by the patients using the fiveface scale (Pearson’s correlation coefficient (0.86) was significant at the 0.01 level). Acetaminophen elixir was provided at home over the first 24 h after surgery by a parent/guardian for 58 (82.9%) local
anaesthetic group children and for 60 (86.9%) placebo group children. This difference was not statistically significant. There were no statistically significant differences between the mean distress scores for the local anaesthetic and placebo group preoperatively, on waking and
A survey of anaesthetists providing anaesthesia for dental procedures in children under 10 years of age in Scotland suggested that the majority asked their dental colleagues to inject local anaesthetic, using lidocaine with epinephrine or prilocaine with felypressin for postoperative pain control15. In this study, no statistically significant difference was demonstrated in pain or distress scores between children receiving 2% lidocaine with 1:200,000 epinephrine or 0.9% sodium chloride as placebo administered by buccal infiltration injection adjacent to the teeth to be removed. Similarly, there was no significant difference in postoperative requirement for the
Table 3. Comparison between mean preoperative distress scores and scores on waking and 30 min postoperatively for children in the local anaesthetic and placebo groups Mean (SD) Local anaesthetic
Placebo
Paired t-value (DF)
P-value
Preoperative On waking Preoperative 30 min postoperative
2.07 2.24 2.08 2.57
(0.27) (0.87) (0.28) (0.83)
1.50 (67)
0.14
4.11 (59)
<0.001
Preoperative On waking Preoperative 30 min postoperative
2.12 2.20 2.13 2.42
(0.45) (0.85) (0.46) (0.74)
0.70 (65)
0.49
2.70 (61)
0.007
Table 4. Comparison between mean distress scores for patients aged 4–6 years and 7–12 years, preoperatively, on waking and 30 min postoperatively Mean (SD)
t-test (DF)
P-value
Preoperatively
Age (years) 4–6 7–12
2.1 (0.4) 2.0 (0.5)
1.60 (136)
0.11
On waking
4–6 7–12
2.6 (0.9) 1.9 (0.7)
2.71 (131)
30 min postoperatively
4–6 7–12
2.6 (0.8) 2.3 (0.6)
2.17 (121)
.008 0.03
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administration of acetaminophen elixir between the two patient groups. These are disappointing findings, particularly as significant pain and distress were identified, and the removal of teeth is a common oral surgery procedure and one of the most common surgical procedures that children undergo in the UK. Similar studies investigating other types of surgery, including tonsilletomy19, orchidopexy13, hypospadias repair3, appendicectomy25 and femoral nailing10, have demonstrated significant reductions in postoperative pain with the use of intraoperative local anaesthesia. Interestingly, in another study when ropivacaine with epinephrine was administered immediately after tonsillectomy the authors were unable to demonstrate any reduction in postoperative pain20. The intraoral infiltration of local anaesthesia causes profound alteration of orofacial sensation particularly affecting the lips and cheek. Patients are often less aware of altered sensation when local anaesthesia is used on areas of the body where the skin is less highly innervated. Most children requiring general rather than local anaesthesia for dental extractions do so because of anxiety, behavioural difficulties or because multiple extractions are required. Many of these children do not attend regularly for dental treatment and may have had no previous experience of the altered sensation associated with a dental local anaesthetic injection. In our study, only 5% of children had previous experience of dental local anaesthetic. Perhaps the altered sensation may have caused distress in patients waking from anaesthesia. There were a number of children who reported pain preoperatively in both groups. This is to be expected as the majority were having teeth removed because of dental caries and acute dental abscesses, and both of these conditions can cause pain. Similarly, distress was recorded preoperatively. This may have been associated with pain or anxiety about the prospect of the surgical procedure or general anaesthesia, or the novel environment. There were significant increases in mean pain scores when comparing the preoperative scores with those on waking, at 30 min postoperatively and at 24 h. Pain scores of ‘severe’ were reported by 12.9% of the local anaesthesia and 11.6% of the placebo group, and ‘very severe’ by 18.6% of the local anaesthesia and 26.1% of the placebo group at 30 min. Children that had 7–10 teeth extracted had significantly greater pain scores on recovery and at 30 min than those having 1–6 teeth extracted. It was disappointing and a mat-
ter of concern to find such a large number of high pain scores, particularly as both groups received both preoperative and postoperative acetaminophen elixir. Other researchers have also noted significant pain after paediatric dental procedures despite preoperative acetaminophen21. The five-face pain score was used to obtain a pain measurement from the child preoperatively and at 30 min postoperatively. A research nurse used the same scale to provide a measure of pain for the child on waking from anaesthesia, when it was thought that the child might be too disorientated to provide a meaningful score for themselves, and at 30 min. All distress scores were undertaken by the research nurse. Pain scores were recorded by the parent at 24 h. Distress and pain may not be easy to distinguish in young patients, and there has been concern that paediatric nurse assessment of pain may be based upon overt distress17. There was good correlation of the scores recorded by the independent research nurse and the child’s self-report of pain as has been shown previously24. Others have suggested that there can be poor agreement between pain ratings by children, parents and practitioners, and there is a lack of clarity about which assessment best approximates the true degree of pain the child is experiencing23. The increase from preoperative distress to on-waking distress was not statistically significant but the increase at 30 min was statistically significant for both groups. The distress at 30 min may therefore have been associated with pain rather than distress because of disorientation on recovery from general anaesthesia. This is supported by the finding that significantly higher distress was reported when 7–10 teeth were extracted when compared with extractions of 1–6 teeth at 30 min postoperatively. Certainly pain has been reported by others as the most significant factor in promoting emotional distress18. Another possible explanation for the postoperative distress could be the bleeding following teeth extractions. Other studies6,12 have reported distress related to bleeding in children who had dental care under general anaesthetic with concern caused by the taste of blood in the mouth. It is important to improve the postoperative experience as distress can lead to behavioural disorders on returning home and a negative attitude to future dental procedures1. More distress was recorded for younger patients than older ones on recovery and at 30 min although there was no significant difference with respect to age in pain scores recorded. This may be because younger children have more limited cognition. It
has been reported in a study of laceration closure that children who exhibited relinquished-control coping experienced more pain during the procedure14. The administration of a range of coping behaviours and improvement in parental support could be useful in reducing pain and distress in children. Young children tend to depend on their parents for support in a fearful situation rather than having their own coping mechanisms. A study comparing the efficacy of parents and nurses in reducing distress associated with immunization pain, however, found that, in general, the nurses’ behaviour was associated with child coping and parents’ behaviour with child distress4. The same study investigated training of the children to cope but found that whilst children demonstrated understanding of the training they did not use these coping skills during the procedure. This area requires further investigation. Four patients were reported by their parent/guardian to have a lip/cheek biting injury at 24 h after surgery. Three of these patients were in the local anaesthetic group and one was in the placebo group. These injuries can cause alarm in the parents and child because of their sinister appearance. It was interesting to find that one patient receiving placebo inflicted such an injury. As few children suffered injury, it is suggested that intraoperative local anaesthesia is not contraindicated on the basis of safety although its use cannot be recommended from this study as no pain-control benefit was demonstrated. The results of this study suggest that the management of pain after oral surgery in paediatric patients presents its own particular challenges, and highlight the need to find alternative strategies to improve the quality of the experience for the child. Surely pain relief is a fundamental human right in addition to being a good clinical and ethical practice. References 1. Al-Bahlani S, Sherriff A, Crawford PJ. Tooth extraction, bleeding and pain control. J R Coll Surg Edinb 2001: 46: 261–264. 2. Bridgman CM, Ashby D, Holloway PJ. An investigation of the effects on children of tooth extraction under general anaesthesia in general dental practice. J Dent 1999: 186: 245–247. 3. Chhibber AK, Perkins FM, Rabinowitz R, Vogt AN, Hulbert WC. Penile block timing for postoperative analgesia of hypospadias repair in children. J Urol 1997: 158: 1156–1159. 4. Cohen LL, Bernard RS, Greco LA, McClellan CB. A child-focused intervention for coping with procedural pain:
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Address: Paul Coulthard School of Dentistry The University of Manchester Higher Cambridge Street Manchester M15 6FH UK Tel: +44 161 275 6650 Fax: +44 161 275 6631 E-mail: [email protected]