Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy

NCT01605903 | Completed Phase 2 Results DMC

• 1 other identifier: 11-054H
• Study Type: interventional
• Target: 741
• Locations: 1 country
• Sites: 5

Brief Summary

Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in children. One risk of tonsillectomy is postoperative bleeding, and this can be more dangerous in children because their blood volume is lower than adults. Ibuprofen, a nonsteroidal anti-inflammatory medication (NSAID), is an effective pain medication. Recent guidelines, published by the American Academy of Otolaryngology, advocated use of ibuprofen after tonsillectomy. However, NSAIDs are associated with altered platelet function and a theoretical increased risk of bleeding after surgery. The investigators would like to explore the effect that ibuprofen has on postoperative bleeding, as well as validate previous studies demonstrating it is an effective pain medication after tonsillectomy.

Conditions

Tonsillectomy; Adenoidectomy

Keywords

Tonsillectomy; adenoidectomy; bleeding; bleeding rates; Tonsillectomy with and without adenoidectomy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Level 3 Postoperative Hemorrhage

  Postoperative hemorrhage is defined as any history of bleeding occurring within the 14 day postoperative period. Hemorrhage will be stratified into 3 levels of severity. Level 1: includes children with a history of postoperative bleeding evaluated and/or treated by a physician in the emergency room, inpatient unit or operating room; Level 2: children requiring inpatient admission for postoperative bleeding regardless of the need for operative intervention; Level 3: children requiring inpatient admission and return to the operating room for control of post-tonsillectomy hemorrhage.

  Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period.

Study Arms (2)

Treatment with Ibuprofen

EXPERIMENTAL

Children in the experimental group will receive grape-flavored ibuprofen 100mg/5 mL. Ibuprofen will be dispensed at 10mg/kg (max dose 600 mg) will be dispensed Q6 hours x 9 days.

Drug: Ibuprofen

Treatment with Acetaminophen

ACTIVE COMPARATOR

Children in the active comparator group will receive grape flavored acetaminophen 160 mg/5 ml. Acetaminophen will be dispensed at 15 mg/kg (max dose 650/mg) Q6 hours x 9 days.

Drug: Acetaminophen

Interventions

Ibuprofen DRUG

Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.

Also known as: Advil, Motrin

Treatment with Ibuprofen

Acetaminophen DRUG

During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.

Also known as: Tylenol

Treatment with Acetaminophen

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients ages 2-18 undergoing tonsillectomy with or without adenoidectomy by electrocautery alone for sleep disordered breathing or infectious tonsillitis will be included.
• Patients with complex medical conditions and craniofacial abnormalities will be included.
• Informed consent and child assent will be required for enrollment

You may not qualify if:

• Patients with a known personal or family history of a bleeding disorder will be excluded.
• Patients with a history of asthma, kidney or liver problems will also be excluded.
• Patients with tonsillectomy or adenoidectomy performed using a cold knife technique, microdebrider, coblation or plasma knife.
• Patients on NSAIDs for other medical conditions, or those who have taken NSAIDs within 1 week of surgery will be excluded.
• Patients with allergy to aspirin or other NSAIDs, acetaminophen, Red Dye #40 or Red Dye #33 will also be excluded.
• Pregnancy testing using urine β-subunit of hCG gonadotropin (beta-HCG) will be performed on all children \> 13 years of age, or those younger than 13 who are menstruating; this is the testing protocol used at the Children's Hospital of Boston. Patients found to be pregnant will be excluded from participation.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• United States Naval Medical Center, San Diego: collaborator
• Brooke Army Medical Center: collaborator
• United States Naval Medical Center, Portsmouth: collaborator
• Madigan Army Medical Center: collaborator

Study Sites (5)

nited States Naval Medical Center, San Diego

San Diego, California, 92134, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Brook Army Medical Center

San Antonio, Texas, 78219, United States

Location

nited States Naval Medical Center, Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Madigan Army Hospital

Tacoma, Washington, 94831, United States

Location

Related Publications (21)

• Erickson BK, Larson DR, St Sauver JL, Meverden RA, Orvidas LJ. Changes in incidence and indications of tonsillectomy and adenotonsillectomy, 1970-2005. Otolaryngol Head Neck Surg. 2009 Jun;140(6):894-901. doi: 10.1016/j.otohns.2009.01.044.

  PMID: 19467411 BACKGROUND

• Bluestone CD. Current indications for tonsillectomy and adenoidectomy. Ann Otol Rhinol Laryngol Suppl. 1992 Jan;155:58-64. doi: 10.1177/00034894921010s112.

  PMID: 1728903 BACKGROUND

• Tom LW, DeDio RM, Cohen DE, Wetmore RF, Handler SD, Potsic WP. Is outpatient tonsillectomy appropriate for young children? Laryngoscope. 1992 Mar;102(3):277-80. doi: 10.1288/00005537-199203000-00009.

  PMID: 1545656 BACKGROUND

• Ross AT, Kazahaya K, Tom LW. Revisiting outpatient tonsillectomy in young children. Otolaryngol Head Neck Surg. 2003 Mar;128(3):326-31. doi: 10.1067/mhn.2003.60.

  PMID: 12646834 BACKGROUND

• Randall DA, Hoffer ME. Complications of tonsillectomy and adenoidectomy. Otolaryngol Head Neck Surg. 1998 Jan;118(1):61-8. doi: 10.1016/S0194-5998(98)70376-6.

  PMID: 9450830 BACKGROUND

• Blakley BW. Post-tonsillectomy bleeding: how much is too much? Otolaryngol Head Neck Surg. 2009 Mar;140(3):288-90. doi: 10.1016/j.otohns.2008.12.005.

  PMID: 19248930 BACKGROUND

• Husband AD, Davis A. Pain after tonsillectomy. Clin Otolaryngol Allied Sci. 1996 Apr;21(2):99-101. doi: 10.1111/j.1365-2273.1996.tb01310.x. No abstract available.

  PMID: 8735391 BACKGROUND

• Harley EH, Dattolo RA. Ibuprofen for tonsillectomy pain in children: efficacy and complications. Otolaryngol Head Neck Surg. 1998 Nov;119(5):492-6. doi: 10.1016/S0194-5998(98)70107-X.

  PMID: 9807075 BACKGROUND

• St Charles CS, Matt BH, Hamilton MM, Katz BP. A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient. Otolaryngol Head Neck Surg. 1997 Jul;117(1):76-82. doi: 10.1016/S0194-59989770211-0.

  PMID: 9230328 BACKGROUND

• REUTER SH, MONTGOMERY WW. ASPIRIN VS ACETAMINOPHEN AFTER TONSILLECTOMY. A COMPARATIVE DOUBLE-BLIND CLINICAL STUDY. Arch Otolaryngol. 1964 Aug;80:214-7. doi: 10.1001/archotol.1964.00750040220021. No abstract available.

  PMID: 14160147 BACKGROUND

• Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.

  PMID: 21493257 BACKGROUND

• Cardwell M, Siviter G, Smith A. Non-steroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003591. doi: 10.1002/14651858.CD003591.pub2.

  PMID: 15846670 BACKGROUND

• Berkowitz RG, Zalzal GH. Tonsillectomy in children under 3 years of age. Arch Otolaryngol Head Neck Surg. 1990 Jun;116(6):685-6. doi: 10.1001/archotol.1990.01870060043006.

  PMID: 2340121 BACKGROUND

• Schafer AI. Effects of nonsteroidal antiinflammatory drugs on platelet function and systemic hemostasis. J Clin Pharmacol. 1995 Mar;35(3):209-19. doi: 10.1002/j.1552-4604.1995.tb04050.x.

  PMID: 7608308 BACKGROUND

• Lewis SR, Nicholson A, Cardwell ME, Siviter G, Smith AF. Nonsteroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2013 Jul 18;2013(7):CD003591. doi: 10.1002/14651858.CD003591.pub3.

  PMID: 23881651 BACKGROUND

• Brigger MT, Cunningham MJ, Hartnick CJ. Dexamethasone administration and postoperative bleeding risk in children undergoing tonsillectomy. Arch Otolaryngol Head Neck Surg. 2010 Aug;136(8):766-72. doi: 10.1001/archoto.2010.133.

  PMID: 20713751 BACKGROUND

• Lister MT, Cunningham MJ, Benjamin B, Williams M, Tirrell A, Schaumberg DA, Hartnick CJ. Microdebrider tonsillotomy vs electrosurgical tonsillectomy: a randomized, double-blind, paired control study of postoperative pain. Arch Otolaryngol Head Neck Surg. 2006 Jun;132(6):599-604. doi: 10.1001/archotol.132.6.599.

  PMID: 16785404 BACKGROUND

• Collison PJ, Mettler B. Factors associated with post-tonsillectomy hemorrhage. Ear Nose Throat J. 2000 Aug;79(8):640-2, 644, 646 passim.

  PMID: 10969475 BACKGROUND

• National Center for Health Statistics, Centers for Disease Control, Advance data 283: ambulatory surgery in the United States, 1994. National Center for Health Statistics. Available on the Web at www.cdc.gov/nchs.

  BACKGROUND

• Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009 Jan 28;(11):1-25.

  PMID: 19294964 BACKGROUND

• Diercks GR, Comins J, Bennett K, Gallagher TQ, Brigger M, Boseley M, Gaudreau P, Rogers D, Setlur J, Keamy D, Cohen MS, Hartnick C. Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2019 Jun 1;145(6):494-500. doi: 10.1001/jamaoto.2019.0269.

  PMID: 30946442 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Gillian Diercks, MD, MPH
• Organization: Massachusetts Eye and Ear Infirmar

gillian_diercks@meei.harvard.edu

617-573-3190

Study Officials

• Christopher J Hartnick, MD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Otology and Laryngology; Chief, Division of Pediatric Otolaryngology; Director, Pediatric Airway, Voice and Swallowing Center

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 25, 2012
• Study Start: May 3, 2012
• Primary Completion: February 15, 2017
• Study Completion: February 15, 2017
• Last Updated: April 24, 2018
• Results First Posted: March 26, 2018

Record last verified: 2018-03

Locations

US (5)