- Email: [email protected]
The pain of nasal tampon removal after nasal surgery: A randomized control trial
Otolaryngology–Head and Neck Surgery (2009) 140, 215-217
ORIGINAL RESEARCH–SINONASAL DISORDERS
The pain of nasal tampon removal after nasal surgery: A randomized control trial Neil Chheda, MD, Arnold E. Katz, MD, Lori Gynizio, RN, and Adam J. Singer, MD, Stony Brook, NY OBJECTIVE: The purpose of this study was to compare the pain and discomfort associated with the removal of two commercially available nasal tampons after nasal surgery. STUDY DESIGN: Prospective, paired, randomized clinical trial. SUBJECTS: Consecutive, consenting, adult patients undergoing nasal surgery. INTERVENTIONS: The nose was packed with a Rapid Rhino tampon (Applied Therapeutics, Tampa, FL) on one side and a Rhino Rocket tampon (Shippert Medical Technologies Corporation, Centennial, CO) on the other. OUTCOMES: The pain of packing removal was assessed with a validated 100-mm visual analog scale. Patient satisfaction was measured on a Likert scale from 1 to 5. RESULTS: In all 13 patients, the pain of removal was greater with the Rhino Rocket Tampon (82.7 ⫾ 20.9 mm) than with the Rapid Rhino tampon (12.0 ⫾ 11.9 mm); the mean difference was 70.7 mm (95% confidence interval [CI], 47.1-78.2 mm; P ⬍ 0.0001). Patient satisfaction was significantly higher with the Rapid Rhino nasal tampon (4.6 ⫾ 1.1 vs 1.5 ⫾ 0.7; mean difference 3.1 [95% CI, 2.6-3.6]; P ⬍ 0.001). CONCLUSIONS: Removal of the Rapid Rhino nasal tampon was significantly less painful and was associated with higher patient satisfaction than the removal of the Rhino Rocket nasal tampon. No sponsorships or competing interests have been disclosed for this article. © 2009 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved.
S
eptoplasty and rhinoseptoplasty are among the most common surgical procedures performed. In 1998, there were 276,000 repairs and operations on the nose.1 A more recent report found that in 2005 there were 200,924 rhinoplasties performed in the United States alone.2 A study of the Department of Human Services in Australia indicated that septoplasty/rhinoplasty accounted for 14.2 percent of all ENT procedures.3 Pain at the time of nasal packing removal is often the most uncomfortable aspect of surgery experienced by patients undergoing septoplasty and/or septorhinoplasty.4 Pain at the time of packing removal may be caused by dislodge-
ment of the blood clot and adherent tissues caused by adherence of the traditional nasal tampons to the nasal septum over the site of the original bleeding. After soaking in water, the Rapid Rhino nasal tampon (Applied Therapeutics, Tampa, FL) becomes coated with a gel-like material that may minimize its adherence to the wounded nasal septum. The present study was designed in an attempt to discover a packing material that would be better tolerated by the patient, resulting in less pain at the time of packing removal. We hypothesized that the pain of removal would be less with the Rapid Rhino than with the Rhino Rocket nasal packings (Shippert Medical Technologies Corporation, Centennial, CO).
METHODS Study Design A prospective, randomized, controlled trial with each patient serving as his/her own control was used to test the study hypothesis. All patients gave written informed consent. The study was approved by the Institutional Review Board at the State University of New York at Stony Brook, Stony Brook, NY. The current study received no industry support.
Setting The study was conducted at an academic university-based medical center with a residency training program in otolaryngology.
Subjects The study subjects consisted of consecutive, consenting, adult patients requiring bilateral nasal packing after septoplasty or septorhinoplasty.
Interventions After completion of the surgery, while the patient was still under general anesthesia, one side of the nose was packed with a Rapid Rhino tampon, and the other side was packed
Received August 12, 2008; revised September 9, 2008; accepted September 9, 2008.
0194-5998/$36.00 © 2009 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved. doi:10.1016/j.otohns.2008.09.012
216
Otolaryngology–Head and Neck Surgery, Vol 140, No 2, February 2009 two tampons concerning the pain of packing removal. Categoric data (patient satisfaction and incidence of bleeding) are summarized as percent frequency of occurrence and compared with a chi-square test. A sample size of 10 patients had 80 percent power to detect a difference of approximately one standard deviation in the paired differences.5
RESULTS
Figure 1 The Rapid Rhino (upper) and Rhino Rocket (lower) nasal tampons.
with the Rhino Rocket tampon (Fig 1). The side and order of packing were randomized. The nasal tampons were gently inserted along the floor of the nasal cavity following the manufacturers’ instructions. With the Rapid Rhino, the tampon was soaked in sterile water for at least 30 seconds or until the fabric completely converted into a gel. The entire length of the catheter was then inserted into the patient’s nostril. The attached balloon was then inflated with approximately 10 to 15 mL of air, and the pilot cuff was checked for firmness. Before patient discharge, the firmness of the pilot cuff was rechecked, and additional air was injected as needed. With the Rhino Rocket, the tampon was inserted into the patient’s nostril using the supplied applicator without soaking it in any solution. One day later, all patients had both nasal tampons removed in the clinic without prior anesthesia or analgesia. The order of packing removal was also randomized. The patients were not informed of which nasal tampon was placed on each side. Furthermore, the investigator who had patients rate the pain of packing removal was also unaware of which tampon was placed on each side.
Outcomes After removal, the pain of packing removal was assessed by the patients with a validated 100-mm visual analog scale marked “not painful ⫽ 0” and “very painful ⫽ 100” at the low and high ends, respectively. Patient satisfaction with the nasal tampon was measured on a Likert scale from “unsatisfied ⫽ 1” to “very satisfied ⫽ 5.” The presence of bleeding and the need for repacking after tampon removal were noted.
Data Analysis Continuous data (pain of packing removal) are summarized with means and 95 percent confidence intervals. A paired t test was used to determine any significant differences between the
During the study period, 15 patients were eligible for study enrollment. Two of the 15 patients withdrew from the study on the day of surgery. Eleven of the 13 patients (84.6%) had undergone a septorhinoplasty. The mean age was 30.1 years; six patients (46%) were female and 10 patients (77%) were white. In all patients, the pain of removal was greater with the Rhino Rocket tampon than with the Rapid Rhino tampon. The pain of Rapid Rhino tampon removal (12.0 ⫾ 11.9 mm) was significantly less than the pain of the Rhino Rocket tampon removal (82.7 ⫾ 20.9 mm) (mean difference, 70.7 mm; 95% confidence interval, 47.1-78.2 mm; P ⬍ 0.0001). Patient satisfaction was significantly higher after removal of the Rapid Rhino nasal tampon (4.6 ⫾ 1.1 vs 1.5 ⫾ 0.7; mean difference, 3.1 [95% confidence interval, 2.63.6]; P ⬍ 0.001). Bleeding occurred with removal of two of the 13 Rhino Rocket tampons but in none of the Rapid Rhino tampons (P ⫽ 0.29). Repacking was not required in any patients.
DISCUSSION Endonasal operations such as septoplasty and rhinoplasty may lead to significant bleeding and hematoma formation. As a result, nasal packings are often inserted postoperatively to reduce these complications. Nasal packings are also recommended to stabilize the cartilaginous and bony skeleton and to prevent synechiae or restenosis. For the latter, some authors recommend packing the nose for several days.6 However, the insertion and removal of the nasal packing may result in significant complications. For example, nasal packings may increase the risk of local and systemic infections. Bilateral nasal packings may also cause hypoxemia.7 As a result, early removal of nasal packings is advantageous. Indeed, a study of 75 patients undergoing septoplasty showed that removal of the nasal packing after 1 day was preferable to packing removal after 2 or more days, resulting in less patient discomfort and increased cost-effectiveness without increasing immediate complications.8 With many of the traditional nasal tampons, early removal may result in dislodgement of the underlying blood clot with the risk of bleeding and need for repacking. As a result, nasal tampons are often left in place for several days increasing patient risks and discomfort. Because the Rapid Rhino forms a gel-like coating, it does not adhere to the
Chheda et al
The pain of nasal tampon removal after nasal . . .
underlying nasal mucosa, allowing early removal without dislodging the underlying clot. Although studies suggest that fibrin sealants may be as effective as nasal tampons after endonasal surgery,9 these are not in wide use. Our study shows that most patients find the removal of the standard nasal tampon very painful as indicated by the high pain scores assigned. Before the use of a more acceptable packing material, the investigators routinely advised patients to take analgesics before they arrived for their packing removal. This practice is also supported by a recent study of 121 patients randomized to placebo or a nonsteroidal anti-inflammatory drug before packing removal that showed that preemptive analgesia decreased the pain during removal of the nasal packing.10 The results of the current study show that removal of the Rapid Rhino nasal tampon results in significantly less pain and greater patient satisfaction than the more traditional Rhino Rocket. Indeed, with the use of the Rapid Rhino nasal tampon, analgesics are no longer recommended or needed in anticipation of this procedure. Our results are in agreement with a similar prior study that compared the pain of tampon insertion and removal after epistaxis with the Rapid Rhino and Rhino Rocket.11 In that study, the use of the Rapid Rhino was associated with significantly less pain of insertion and removal than the Rhino Rocket.
217
There was no significant difference in the incidence of bleeding at the time of removal.
AUTHOR INFORMATION From the Division of Otolaryngology–Head and Neck Surgery, Department of Surgery, and the Department of Emergency Medicine (AJS), State University of New York at Stony Brook. Corresponding author: Arnold E. Katz, MD, Department of Surgery, HSC T-19-090, Stony Brook, NY 11794. E-mail address: [email protected].
AUTHOR CONTRIBUTIONS Neil Chheda, design, manuscript review, data collection; Arnold E. Katz, conception, design, data collection, manuscript review, supervision; Adam J. Singer, conception, design, data analysis, manuscript review; Lori Gynizio, data collection, manuscript review.
FINANCIAL DISCLOSURE None.
REFERENCES LIMITATIONS The major limitation of our study was the inability to mask the physicians and all investigators to the assigned nasal tampons. This had the potential to introduce significant observer bias. We attempted to minimize any resulting bias by not informing patients which tampon was inserted in each side of the nose. Furthermore, the pain scores were collected by an investigator, who also was unaware of treatment assignment, after the nasal tampons had already been removed. Another limitation is the small sample size. Thus, our study may have been underpowered to detect small differences in the rate of adverse events such as bleeding.
CONCLUSION Removal of the Rapid Rhino nasal tampon was significantly less painful and was associated with higher patient satisfaction than the removal of the Rhino Rocket nasal tampon.
1. Owings MF, Kozak LJ. Ambulatory and inpatient procedures in the United States, 1996. National Center for Health Statistics. Vital Health Stat 1998;13:1–119. 2. Available at: http://www.cosmeticplasticsurgerystatistics.com/statistics. html. Accessed. 3. Available at: http://211.26.193.60/ahs/archive/esis/ent.html. Accessed. 4. Weber R, Hochapfel F, Draf W. Packing and stents in endonasal surgery. Rhinology 2000;38:49 – 62. 5. Cohen J. Statistical Power analysis for the behavioral sciences. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988. 6. Weber RK, Kay U. Is packing of the nose up-to-date ? Laryngorhinootologie 2003;82:650 – 4. 7. Ogretmenoglu O, Yilmaz T, Rahimi K, et al. The effect on arterial blood gases and heart rate of bilateral nasal packing. Eur Arch Otorhinolaryngol 2002;259:63– 6. 8. Hajjionnaou JK, Bizaki A, Fragiadakis G, et al. Optimal time for nasal packing removal after septoplasty. A comparative study. Rhinology 2007;45:68 –71. 9. Vaiman M, Sarfati S, Slamcovitch M, et al. Fibrin sealant: alternative to nasal packing in endonasal operations. A prospective randomized study. Isr Med Assoc J 2005;7:571– 4. 10. Yilmazer C, Sener M, Yilmaz I, et al. Pre-emptive analgesia for removal of nasal packing: a double-blind placebo controlled study. Auris Nasus Larynx 2007;34:471–5. 11. Singer AJ, Blanda M, Cronin K, et al. Comparison of nasal tampons for the treatment of epistaxis in the emergency department: a randomized controlled trial. Ann Emerg Med 2005;45:134 –9.
ORIGINAL RESEARCH–SINONASAL DISORDERS
The pain of nasal tampon removal after nasal surgery: A randomized control trial Neil Chheda, MD, Arnold E. Katz, MD, Lori Gynizio, RN, and Adam J. Singer, MD, Stony Brook, NY OBJECTIVE: The purpose of this study was to compare the pain and discomfort associated with the removal of two commercially available nasal tampons after nasal surgery. STUDY DESIGN: Prospective, paired, randomized clinical trial. SUBJECTS: Consecutive, consenting, adult patients undergoing nasal surgery. INTERVENTIONS: The nose was packed with a Rapid Rhino tampon (Applied Therapeutics, Tampa, FL) on one side and a Rhino Rocket tampon (Shippert Medical Technologies Corporation, Centennial, CO) on the other. OUTCOMES: The pain of packing removal was assessed with a validated 100-mm visual analog scale. Patient satisfaction was measured on a Likert scale from 1 to 5. RESULTS: In all 13 patients, the pain of removal was greater with the Rhino Rocket Tampon (82.7 ⫾ 20.9 mm) than with the Rapid Rhino tampon (12.0 ⫾ 11.9 mm); the mean difference was 70.7 mm (95% confidence interval [CI], 47.1-78.2 mm; P ⬍ 0.0001). Patient satisfaction was significantly higher with the Rapid Rhino nasal tampon (4.6 ⫾ 1.1 vs 1.5 ⫾ 0.7; mean difference 3.1 [95% CI, 2.6-3.6]; P ⬍ 0.001). CONCLUSIONS: Removal of the Rapid Rhino nasal tampon was significantly less painful and was associated with higher patient satisfaction than the removal of the Rhino Rocket nasal tampon. No sponsorships or competing interests have been disclosed for this article. © 2009 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved.
S
eptoplasty and rhinoseptoplasty are among the most common surgical procedures performed. In 1998, there were 276,000 repairs and operations on the nose.1 A more recent report found that in 2005 there were 200,924 rhinoplasties performed in the United States alone.2 A study of the Department of Human Services in Australia indicated that septoplasty/rhinoplasty accounted for 14.2 percent of all ENT procedures.3 Pain at the time of nasal packing removal is often the most uncomfortable aspect of surgery experienced by patients undergoing septoplasty and/or septorhinoplasty.4 Pain at the time of packing removal may be caused by dislodge-
ment of the blood clot and adherent tissues caused by adherence of the traditional nasal tampons to the nasal septum over the site of the original bleeding. After soaking in water, the Rapid Rhino nasal tampon (Applied Therapeutics, Tampa, FL) becomes coated with a gel-like material that may minimize its adherence to the wounded nasal septum. The present study was designed in an attempt to discover a packing material that would be better tolerated by the patient, resulting in less pain at the time of packing removal. We hypothesized that the pain of removal would be less with the Rapid Rhino than with the Rhino Rocket nasal packings (Shippert Medical Technologies Corporation, Centennial, CO).
METHODS Study Design A prospective, randomized, controlled trial with each patient serving as his/her own control was used to test the study hypothesis. All patients gave written informed consent. The study was approved by the Institutional Review Board at the State University of New York at Stony Brook, Stony Brook, NY. The current study received no industry support.
Setting The study was conducted at an academic university-based medical center with a residency training program in otolaryngology.
Subjects The study subjects consisted of consecutive, consenting, adult patients requiring bilateral nasal packing after septoplasty or septorhinoplasty.
Interventions After completion of the surgery, while the patient was still under general anesthesia, one side of the nose was packed with a Rapid Rhino tampon, and the other side was packed
Received August 12, 2008; revised September 9, 2008; accepted September 9, 2008.
0194-5998/$36.00 © 2009 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved. doi:10.1016/j.otohns.2008.09.012
216
Otolaryngology–Head and Neck Surgery, Vol 140, No 2, February 2009 two tampons concerning the pain of packing removal. Categoric data (patient satisfaction and incidence of bleeding) are summarized as percent frequency of occurrence and compared with a chi-square test. A sample size of 10 patients had 80 percent power to detect a difference of approximately one standard deviation in the paired differences.5
RESULTS
Figure 1 The Rapid Rhino (upper) and Rhino Rocket (lower) nasal tampons.
with the Rhino Rocket tampon (Fig 1). The side and order of packing were randomized. The nasal tampons were gently inserted along the floor of the nasal cavity following the manufacturers’ instructions. With the Rapid Rhino, the tampon was soaked in sterile water for at least 30 seconds or until the fabric completely converted into a gel. The entire length of the catheter was then inserted into the patient’s nostril. The attached balloon was then inflated with approximately 10 to 15 mL of air, and the pilot cuff was checked for firmness. Before patient discharge, the firmness of the pilot cuff was rechecked, and additional air was injected as needed. With the Rhino Rocket, the tampon was inserted into the patient’s nostril using the supplied applicator without soaking it in any solution. One day later, all patients had both nasal tampons removed in the clinic without prior anesthesia or analgesia. The order of packing removal was also randomized. The patients were not informed of which nasal tampon was placed on each side. Furthermore, the investigator who had patients rate the pain of packing removal was also unaware of which tampon was placed on each side.
Outcomes After removal, the pain of packing removal was assessed by the patients with a validated 100-mm visual analog scale marked “not painful ⫽ 0” and “very painful ⫽ 100” at the low and high ends, respectively. Patient satisfaction with the nasal tampon was measured on a Likert scale from “unsatisfied ⫽ 1” to “very satisfied ⫽ 5.” The presence of bleeding and the need for repacking after tampon removal were noted.
Data Analysis Continuous data (pain of packing removal) are summarized with means and 95 percent confidence intervals. A paired t test was used to determine any significant differences between the
During the study period, 15 patients were eligible for study enrollment. Two of the 15 patients withdrew from the study on the day of surgery. Eleven of the 13 patients (84.6%) had undergone a septorhinoplasty. The mean age was 30.1 years; six patients (46%) were female and 10 patients (77%) were white. In all patients, the pain of removal was greater with the Rhino Rocket tampon than with the Rapid Rhino tampon. The pain of Rapid Rhino tampon removal (12.0 ⫾ 11.9 mm) was significantly less than the pain of the Rhino Rocket tampon removal (82.7 ⫾ 20.9 mm) (mean difference, 70.7 mm; 95% confidence interval, 47.1-78.2 mm; P ⬍ 0.0001). Patient satisfaction was significantly higher after removal of the Rapid Rhino nasal tampon (4.6 ⫾ 1.1 vs 1.5 ⫾ 0.7; mean difference, 3.1 [95% confidence interval, 2.63.6]; P ⬍ 0.001). Bleeding occurred with removal of two of the 13 Rhino Rocket tampons but in none of the Rapid Rhino tampons (P ⫽ 0.29). Repacking was not required in any patients.
DISCUSSION Endonasal operations such as septoplasty and rhinoplasty may lead to significant bleeding and hematoma formation. As a result, nasal packings are often inserted postoperatively to reduce these complications. Nasal packings are also recommended to stabilize the cartilaginous and bony skeleton and to prevent synechiae or restenosis. For the latter, some authors recommend packing the nose for several days.6 However, the insertion and removal of the nasal packing may result in significant complications. For example, nasal packings may increase the risk of local and systemic infections. Bilateral nasal packings may also cause hypoxemia.7 As a result, early removal of nasal packings is advantageous. Indeed, a study of 75 patients undergoing septoplasty showed that removal of the nasal packing after 1 day was preferable to packing removal after 2 or more days, resulting in less patient discomfort and increased cost-effectiveness without increasing immediate complications.8 With many of the traditional nasal tampons, early removal may result in dislodgement of the underlying blood clot with the risk of bleeding and need for repacking. As a result, nasal tampons are often left in place for several days increasing patient risks and discomfort. Because the Rapid Rhino forms a gel-like coating, it does not adhere to the
Chheda et al
The pain of nasal tampon removal after nasal . . .
underlying nasal mucosa, allowing early removal without dislodging the underlying clot. Although studies suggest that fibrin sealants may be as effective as nasal tampons after endonasal surgery,9 these are not in wide use. Our study shows that most patients find the removal of the standard nasal tampon very painful as indicated by the high pain scores assigned. Before the use of a more acceptable packing material, the investigators routinely advised patients to take analgesics before they arrived for their packing removal. This practice is also supported by a recent study of 121 patients randomized to placebo or a nonsteroidal anti-inflammatory drug before packing removal that showed that preemptive analgesia decreased the pain during removal of the nasal packing.10 The results of the current study show that removal of the Rapid Rhino nasal tampon results in significantly less pain and greater patient satisfaction than the more traditional Rhino Rocket. Indeed, with the use of the Rapid Rhino nasal tampon, analgesics are no longer recommended or needed in anticipation of this procedure. Our results are in agreement with a similar prior study that compared the pain of tampon insertion and removal after epistaxis with the Rapid Rhino and Rhino Rocket.11 In that study, the use of the Rapid Rhino was associated with significantly less pain of insertion and removal than the Rhino Rocket.
217
There was no significant difference in the incidence of bleeding at the time of removal.
AUTHOR INFORMATION From the Division of Otolaryngology–Head and Neck Surgery, Department of Surgery, and the Department of Emergency Medicine (AJS), State University of New York at Stony Brook. Corresponding author: Arnold E. Katz, MD, Department of Surgery, HSC T-19-090, Stony Brook, NY 11794. E-mail address: [email protected].
AUTHOR CONTRIBUTIONS Neil Chheda, design, manuscript review, data collection; Arnold E. Katz, conception, design, data collection, manuscript review, supervision; Adam J. Singer, conception, design, data analysis, manuscript review; Lori Gynizio, data collection, manuscript review.
FINANCIAL DISCLOSURE None.
REFERENCES LIMITATIONS The major limitation of our study was the inability to mask the physicians and all investigators to the assigned nasal tampons. This had the potential to introduce significant observer bias. We attempted to minimize any resulting bias by not informing patients which tampon was inserted in each side of the nose. Furthermore, the pain scores were collected by an investigator, who also was unaware of treatment assignment, after the nasal tampons had already been removed. Another limitation is the small sample size. Thus, our study may have been underpowered to detect small differences in the rate of adverse events such as bleeding.
CONCLUSION Removal of the Rapid Rhino nasal tampon was significantly less painful and was associated with higher patient satisfaction than the removal of the Rhino Rocket nasal tampon.
1. Owings MF, Kozak LJ. Ambulatory and inpatient procedures in the United States, 1996. National Center for Health Statistics. Vital Health Stat 1998;13:1–119. 2. Available at: http://www.cosmeticplasticsurgerystatistics.com/statistics. html. Accessed. 3. Available at: http://211.26.193.60/ahs/archive/esis/ent.html. Accessed. 4. Weber R, Hochapfel F, Draf W. Packing and stents in endonasal surgery. Rhinology 2000;38:49 – 62. 5. Cohen J. Statistical Power analysis for the behavioral sciences. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988. 6. Weber RK, Kay U. Is packing of the nose up-to-date ? Laryngorhinootologie 2003;82:650 – 4. 7. Ogretmenoglu O, Yilmaz T, Rahimi K, et al. The effect on arterial blood gases and heart rate of bilateral nasal packing. Eur Arch Otorhinolaryngol 2002;259:63– 6. 8. Hajjionnaou JK, Bizaki A, Fragiadakis G, et al. Optimal time for nasal packing removal after septoplasty. A comparative study. Rhinology 2007;45:68 –71. 9. Vaiman M, Sarfati S, Slamcovitch M, et al. Fibrin sealant: alternative to nasal packing in endonasal operations. A prospective randomized study. Isr Med Assoc J 2005;7:571– 4. 10. Yilmazer C, Sener M, Yilmaz I, et al. Pre-emptive analgesia for removal of nasal packing: a double-blind placebo controlled study. Auris Nasus Larynx 2007;34:471–5. 11. Singer AJ, Blanda M, Cronin K, et al. Comparison of nasal tampons for the treatment of epistaxis in the emergency department: a randomized controlled trial. Ann Emerg Med 2005;45:134 –9.