Ketoprofen for postoperative pain after uvulopalatopharyngoplasty and tonsillectomy: Two-week follow-up study

Ketoprofen for postoperative pain after uvulopalatopharyngoplasty and tonsillectomy: Two-week follow-up study

Ketoprofen for postoperative pain after uvulopalatopharyngoplasty and tonsillectomy: Two-week follow-up study ELINA NIKANNE, MD, PHD, JUKKA VIRTANIE...

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Ketoprofen for postoperative pain after uvulopalatopharyngoplasty and tonsillectomy: Two-week follow-up study ELINA NIKANNE,

MD, PHD,

JUKKA VIRTANIEMI,

MD, PHD,

M. AHO,

OBJECTIVE: In our previous study, we reported that both uvulopalatopharyngoplasty (UPPP) and tonsillectomy are associated with unacceptable intense pain during the first 24 hours after surgery. To investigate the pain progression at home, we followed the same 53 patients for 14 days after surgery. Twenty-two patients underwent tonsillectomy and 31 patients underwent UPPP. STUDY DESIGN: A prospective, longitudinal, parallel-group study was conducted. METHODS: Beginning on the first postoperative day, the patients were allowed to use 50 mg ketoprofen capsules at a dosage of 5 mg/kg/24 hr. The patients evaluated their own pain four times a day for the first 5 days. Two weeks after the surgery during a follow-up visit patients reported the present pain; and a total consumption of analgesics, and all adverse events for 14 days. RESULTS: Patients in both study groups had significant pain, especially in the morning, for the first week after surgery. In half of the patients, severe pain interfered with eating and sleeping, and in one third of the patients, the pain lasted 2 weeks or longer. The need for ketoprofen was significantly higher after UPPP than that after tonsillectomy (P ⴝ 0.001). One patient after tonsillectomy and 3 patients after UPPP needed electrocautery to stop secondary bleeding. CONCLUSIONS: Both UPPP and tonsillectomy are as-

From the Departments of Otorhinolaryngology (Drs Nikanne, Virtaniemi, and Aho) and Anesthesiology and Intensive Care (Dr Kokki), Kuopio University Hospital. Currently, Dr Nikanne is at the Central Finland Central Hospital, Jyva¨skyla¨, Finland, and Dr Aho is at the North Karelian Central Hospital, Joensuu, Finland. This study was financially supported by Kuopio University Hospital EVO-funding. Reprint requests: Hannu Kokki, MD, Department of Anesthesiology and Intensive Care, Kuopio University Hospital, PO Box 1777, FIN-70211 Kuopio, Finland; e-mail, [email protected]. Copyright © 2003 by the American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. 0194-5998/2003/$30.00 ⫹ 0 doi:10.1016/S0194-5998(03)01579-1

MD,

and HANNU KOKKI,

MD, PHD,

Kuopio, Finland

sociated with intense postoperative pain. Standard ketoprofen capsules are too short-acting to ensure undisturbed sleep. (Otolaryngol Head Neck Surg 2003;129:577-81.)

U vulopalatopharyngoplasty

(UPPP) and tonsillectomy are associated with severe pain during the first postoperative days.1-4 Two previous studies have demonstrated that the pain treatment protocol in our institution after UPPP is not optimal, because more than 40% of the patients had high pain scores during the first 24 postoperative hours.5,6 This undesirable situation came to light in our quality assurance program. Suboptimal pain control is unacceptable because it causes patients undue distress and discomfort. Nonsteroidal antiinflammatory drugs (NSAIDs) have been proved to be effective in patients with moderate to severe postoperative pain.7 Ketoprofen is an NSAID that belongs to the group of phenylpropionic acid derivatives and has been in clinical use since 1973.8 Ketoprofen is a widely used analgesic in Finland, and for a decade it has also been available without prescription. After tonsillectomy ketoprofen is as effective as diclofenac and ketorolac,9 but ketoprofen seems to perform more rapidly.10 Moreover, ketoprofen is less likely to disturb hemostatic function compared with some other NSAIDs,11 which is an important safety factor during surgery associated with a high risk of postoperative bleeding. Ongoing efforts to contain costs have had an impact on the delivery of care; thus in many institutions patients undergoing UPPP or tonsillectomy are discharged within 24 hours. However, during short-stay surgery, it is essential to preserve the quality of care after discharge. Patients need clear instructions and support for their pain treatment at home. To be able to give proper instructions, it is important to understand pain progression after UPPP. Therefore our first objective was to evaluate pain progression after UPPP during the 577

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first 14 days. A second objective was to determine the need, efficacy, and safety of ketoprofen in this special patient group. Patients undergoing tonsillectomy were selected as a control group because tonsillectomy is a common operation in otorhinolaryngology and because tonsillectomy is known to be associated with intense or moderate pain after surgery.4 MATERIALS AND METHODS The study was approved by our Ethics Committee and was conducted in accordance with the current version of the Declaration of Helsinki. The patients were informed and provided written consent. They were instructed in the use of a 100-mm visual analog scale (VAS) during the preoperative visit. We studied 53 consecutive patients, ASA I-II and aged 21 to 62 years, who underwent UPPP (n ⫽ 31) or tonsillectomy (n ⫽ 22) under standardized general anesthesia. We have described the pain and recovery of these same patients during the first 24 hours in a previous report, where we found that both UPPP and tonsillectomy were associated with intense postoperative pain during the first 24 postoperative hours.6 To investigate recovery at home, we followed these patients for 2 weeks after surgery. The study design was prospective, longitudinal with parallel groups. All patients undergoing UPPP were studied by overnight polysomnography preoperatively. The oxygen desaturation index, defined as the number of 4% oxygen desaturation episodes per 1 hour, was evaluated. Patient selection for UPPP was based on clinical history (symptoms of habitual snoring or obstructive sleep apnea syndrome); a physical examination that showed obstruction at the level of the nasopharynx or oropharynx; and polysomnography result (oxygen desaturation index ⬎5). The patients with tonsillectomy had had recurrent or chronic tonsillitis. Patients were excluded if they had a known allergy to ketoprofen or another NSAID, asthma, kidney or liver dysfunction, or hemorrhagic diathesis. A standardized endotracheal anesthesia was used in each patient. Every UPPP surgery included tonsillectomy. Both tonsillectomy and UPPP surgery were performed using electrodissection technique.6 All patients received penicillin (2 million

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IU twice daily) during the first 5 postoperative days. The tonsillectomy patients were discharged on the first postoperative day, and the UPPP patients, on the second postoperative day. Beginning on the first postoperative morning, the patients were allowed to use ketoprofen (Orudis; RhonePoulenc-Rorer, Helsinki, Finland) 50 mg capsules every 30 minutes up to 5 mg/kg/24 hr. No other analgesic medication was permitted during the study. At home the patients evaluated their worst pain since the last expression at 8 AM, 12 NOON, and 2 and 9 PM for the first 5 postoperative days using a VAS of 100 mm (0 mm ⫽ “no pain” and 100 mm ⫽ “worst possible pain”). At the same time the pain relief achieved with ketoprofen capsules was expressed on a categorical rating scale: none, slight, good, or complete pain relief. Moreover, the patients recorded the use of analgesic for each 24 hours on the follow-up chart. The patients had a follow-up visit at 2 weeks after the operation. During this visit, they returned the follow-up charts, and the physician checked that it was completed properly. The patients reported the intensity of present pain, the number of days with pain, and on how many days the pain was severe, moderate, and slight. The cumulative consumption of ketoprofen capsules and any adverse events was recorded. The patients also reported the worse postoperative problem at home: pain, difficulty in swallowing, or difficulty in other functions. Statistics Analysis of categorical data and proportions was performed using the ␹2 test. Analysis of continuous data between the UPPP group and the TE group was performed using the Mann-Whitney U test. Comparison of the intensity of pain between 8 AM, 12 NOON, and 2 and 9 PM was performed using the Wilcoxon rank sum test with a Bonferroni correction. A P value of ⱕ0.05 was considered significant. The continuous data are expressed as mean ⫾ SD, median (range). RESULTS All 53 patients came to the follow-up visit, which enabled us to gather a detailed profile of the recovery for all patients. In the UPPP group, there were more males (male-female ratio, 29:2 versus

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Table 1. Consumption of ketoprofen capsules during the first 5 days and total consumption during 2 weeks after surgery Variable

Tonsillectomy (n ⴝ 22)

P

Uvulopalatopharyngoplasty (n ⴝ 31)

3 (1 to 7) 6 (3 to 10) 7 (3 to 14) 6 (4 to 10) 6 (2 to 10) 42 (20 to 90)

0.001 0.001 0.006 0.006 0.001 0.001

8 (2 to 10) 8 (3 to 14) 9 (4 to 16) 9 (2 to 16) 10 (3 to 19) 65 (15 to 127)

First postoperative day Second postoperative day Third postoperative day Fourth postoperative day Fifth postoperative day Total consumption during first 14 postoperative days Data are mean number of 50 mg capsules (range).

12:10), and they were older (mean age, 45 versus 32 years); in addition, their weight (86 versus 77 kg), and hence body mass index (27 versus 25 kg/m2), was higher compared with the patients in the tonsillectomy group.6 This was accepted because habitual snoring and obstructive sleep apnea syndrome are most common in middle-aged, obese men. Because UPPP is a more extended procedure, the duration of the surgery (35 versus 21 minutes) was longer than tonsillectomy. Recovery during the First 5 Postoperative Days The patients in the UPPP group took significantly more ketoprofen capsules during the first 5 postoperative days compared with the patients in the tonsillectomy group (P ⫽ 0.001 to 0.006) (Table 1). In both groups, the pain scores were highest in the morning assessments compared with the later assessments during the day (P ⫽ 0.001 to 0.045). There was no significant difference between the groups in the pain scores, although the scores in the tonsillectomy group tended to be higher in the morning assessments compared with the UPPP group (Fig 1). Inadequate pain relief was recorded as a maximal pain score higher than 50 mm at least once a day. On the first postoperative day, 11 patients (35%) in the UPPP group and 8 patients (36%) in the tonsillectomy group had inadequate pain relief. During the next days, inadequate pain relief was even more common, and by the fifth postoperative day, 17 patients (55%) in the UPPP group and 15 patients (64%) in the tonsillectomy group expressed pain scores higher than 50 mm.

Fig 1. Mean expressed pain scores on a 100-mm VAS of UPPP (solid line) and tonsillectomy (dotted line) during the first 5 postoperative days. The numbers on the horizontal axis represent the time of day at which VAS evaluations were made.

At 2 weeks, 12 patients (39%) in the UPPP group and 7 patients (32%) in the tonsillectomy group still experienced pain. However, pain was slight because mean pain on a VAS of 100 mm was no more than 6 mm (range, 0 to 25) in the UPPP group and 4 mm (range, 0 to 22) in the tonsillectomy group. Fifteen patients (48%) in the UPPP group and 11 patients (50%) in the tonsillectomy group reported that pain during swallowing was the worst problem at home. Pain at rest was the worst complaint among 9 patients (29%) in the UPPP group and 5 patients (22%) in the tonsillectomy group. The total consumption of ketoprofen capsules during the 2 weeks was higher in the patients with UPPP compared to the patients with tonsillectomy (P ⫽ 0.001) (Table 1). Three patients (10%) in the UPPP group and 2 patients (9%) in the tonsillectomy group had to wake up at night to take anal-

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gesics. More than 90% of the patients in both groups evaluated that significant pain relief was achieved with ketoprofen capsules. Adverse Effects Three patients in both groups developed postoperative bleeding. The bleeding was self-limited in 2 patients in the tonsillectomy group. Three patients in the UPPP group and 1 patient in the tonsillectomy group were treated with electrocautery in the outpatient department. Thereafter there was no difference in outcome between the patients who had bleeding compared with those who did not bleed. There were no other serious adverse effects and no patient discontinued the analgesic treatment. DISCUSSION Effective pain treatment remains a challenge after UPPP and tonsillectomy. In agreement with previous reports,1,2 the present study shows that UPPP and tonsillectomy produce significant postoperative pain in most patients. In the present survey, half of the patients reported the worst pain to be higher than 50 mm on a 100-mm VAS during the first 5 postoperative days. This is not acceptable because effective pain treatment is a part of our quality assurance program. As expected the patients with UPPP used significantly more ketoprofen capsules than the patients with tonsillectomy. More than 90% of the patients reported that ketoprofen was effective; in other words, the analgesic effect of ketoprofen was graded as either complete, good, or slight. However, most of the patients with UPPP used more ketoprofen capsules than what were prescribed. Moreover, sufficient analgesic treatment that continues to the next morning was not present, because the highest pain scores were recorded in the morning assessments. The half-time of ketoprofen is short, just 2 hours, which seems to be too short to provide pain relief for the whole night. Unnecessary short analgesic action has also been shown to occur with other drugs. Toma and coworkers used co-proxamol and paracetamol as analgesic among patients with tonsillectomy and found pain to be most severe in morning.1 Therefore it would be advantageous to use a slowreleasing drug formula in the evening to ensure an

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undisturbed sleep. Moreover, severe pain disturbs not only sleep but also other activities of daily living. In the present study, half of the patients had problems with eating because swallowing was so painful. Thus pain treatment should be improved to allow patients a peaceful recovery after UPPP and tonsillectomy. Further studies are needed to see if ketoprofen supplemented with, for example, paracetamol or paracetamol-codeine performs better. Because recent studies indicate that pain after UPPP and tonsillectomy continues over the first postoperative week,1-3 we followed the patients for 2 weeks. The expectations were confirmed because most patients experienced significant pain over the first week. Moreover, at the 2-week follow-up visit, 1 of 3 patients still experienced some pain, which should be taken into consideration in the length of the acceptable sick leave. A similar pain progression was found by Wexler3; recovery after tonsillectomy using either electrodissection or sharp dissection technique was compared in that study. NSAID analgesic was given intramuscularly 5 to 7 days after the surgery, although there are no data suggesting that intramuscular NSAID analgesics performs any better than same drugs given orally.12 All NSAID analgesics are known to prolong bleeding time13 and therefore may cause bleeding after UPPP and tonsillectomy. However, both diclofenac2,5,11 and ketoprofen6,11,14 have been used after these operations without clinically significant bleeding in the early postoperative period. None of the patients in the present study developed primary hemorrhage,6 but 6 of 53 patients (11%) had secondary bleeding at home after the surgery. Bleeding was self-limited in 2 patients, but 4 patients (8%) had to return to the hospital for hemostasis. It seems that the incidence of postoperative bleeding after UPPP is higher than after tonsillectomy. This is supported by the results of the study of Haavisto and Suonpa¨ a¨ ,15 in which they evaluated recovery after UPPP. In that study, 14% of the patients undergoing UPPP experienced secondary hemorrhage and most of them needed surgical intervention to stop the bleeding. Haavisto and Suonpa¨ a¨ 15 did not report the analgesic treatment they used, and therefore no further conclusions can be drawn about the safety of ketoprofen

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in this respect. Moreover, the number of patients in these studies is too small to draw any firm conclusions of the risk for postoperative bleeding after UPPP. However, a recent study indicates that different NSAIDs interfere with platelet function to different degrees.11 Thus the selection of nonopioid analgesic should be considered carefully in a patient undergoing surgery that entails a high risk of postoperative bleeding or has any reduction in hemostatic function. CONCLUSION Both UPPP and tonsillectomy produce intense pain; therefore patients need safe and effective pain treatment after discharge. Ketoprofen seems to be an effective nonopioid analgesic after UPPP and tonsillectomy, although it was found to be too short acting to ensure undisturbed sleep. However, the safety of ketoprofen is open because of a rather high incidence of postoperative hemorrhage. REFERENCES

1. Toma AG, Blanshard J, Eynon-Lewis N, et al. Posttonsillectomy pain: the first ten days. J Laryngol Otol 1995;109:963-4. 2. Ejnell H, Bjo¨ rkman R, Wåhlander L, et al. Treatment of postoperative pain with diclofenac in uvuloplatopharyngoplasty. Br J Anaesth 1992;68:76-80. 3. Wexler DB. Recovery after tonsillectomy: electrodissection vs. sharp dissection techniques. Otolaryngol Head Neck Surg 1996;114:576-581.

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4. Warnock FF, Lander J. Pain progression, intensity and outcomes following tonsillectomy. Pain 1998;75:37-45. 5. Hendolin H, Kansanen M, Koski E, et al. Propofolnitrous oxide versus thiopenthone-isoflurane-nirtous oxide anesthesia for uvulopharyngoplasty in patients with sleep apnoea. Acta Anaesthesiol Scand 1994;38:694-8. 6. Virtaniemi J, Kokki H, Nikanne E, et al. Ketoprofen and fentanyl for pain after uvulopalatopharyngoplasty and tonsillectomy. Laryngoscope 1999;109:1950-4. 7. Dahl JB, Kehlet H. Non-steroidal anti-inflammatory drugs: rationale for use in severe postoperative pain. Br J Anaesth 1991;66:703-12. 8. Veys EM. 20 Years’ experience with ketoprofen. Scand J Rheumatol 1991;90(suppl):3-44. 9. Tarkkila P, Saarnivaara L. Ketoprofen, diclofenac or ketorolac for pain after tonsillectomy in adults? Br J Anaesth 1999;82:56-60. 10. Kostamovaara PA, Hendolin H, Kokki H, et al. Ketorolac, diclofenac and ketoprofen are equally efficacious for pain relief after total hip replacement surgery. Br J Anaesth 1998;81:369-72. 11. Niemi TT, Taxell C, Rosenberg PH. Comparison of the effects of intravenous ketoprofen, ketorolac and diclofenac on platelet function in volunteers. Acta Anaesthesiol Scand 1997;41:1353-8. 12. Tramer MR, Williams JE, Carroll D, et al. Comparing analgesic efficacy of non-streroidal anti-inflammatory drugs given different routes in acute and chronic pain: a qualitative systematic review. Acta Anaesthesiol Scand 1998;42:71-9. 13. Vane JR, Botting RM. Mechanism of action of nonsteroidal anti-inflammatory drugs. Am J Med 1998;104:2-8. 14. Nikanne E, Kokki H, Tuovinen K. Postoperative pain after adenoidectomy in children. Br J Anaesth 1999;82: 886-9. 15. Haavisto L, Suonpa¨ a¨ J. Complications of uvulopalatopharyngoplasty. Clin Otolaryngol 1994;19:243-7.