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

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ClinicalTrials.gov Identifier: NCT01605903
Recruitment Status : Completed
First Posted : May 25, 2012
Results First Posted : March 26, 2018
Last Update Posted : April 24, 2018
Sponsor:
Collaborators:
United States Naval Medical Center, San Diego
Brooke Army Medical Center
United States Naval Medical Center, Portsmouth
Madigan Army Medical Center
Information provided by (Responsible Party):
Christopher Hartnick, M.D., Massachusetts Eye and Ear Infirmary

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Tonsillectomy
Adenoidectomy
Interventions Drug: Ibuprofen
Drug: Acetaminophen
Enrollment 741
Recruitment Details 741 patients were enrolled between May 3, 2012 and January 20, 2017 at participating institutions (Massachusetts Eye and Ear Infirmary, Boston; Naval Medical Center San Diego, San Diego; Naval Medical Center Portsmouth, Portsmouth; and Madigan Army Medical Center, Tacoma) prior to surgery.
Pre-assignment Details All enrolled subjects were randomized to a treatment group, however 53 (7.2%) patients did not receive the study medication , either because they dropped out prior to the first dose of study medication, the procedure was cancelled, alternative surgical technique was used, pharmacy error, or IV acetaminophen was administered.
Arm/Group Title Treatment With Ibuprofen Treatment With Acetaminophen
Hide Arm/Group Description

Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.

Ibuprofen: 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.

Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.

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

Period Title: Overall Study
Started 345 343
Completed 345 343
Not Completed 0 0
Arm/Group Title Treatment With Ibuprofen Treatment With Acetaminophen Total
Hide Arm/Group Description

Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery. 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.

Ibuprofen: 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.

Children will be randomly assigned to either the treatment arm or active comparator prior to surgery. Children in the active comparator group (Acetaminophen) will receive grape flavored 160 mg/5 ml acetaminophen. Acetaminophen will be dispensed at 15 mg/kg (max dose 650/mg) Q6.

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

Total of all reporting groups
Overall Number of Baseline Participants 345 343 688
Hide Baseline Analysis Population Description
Race and Ethnicity not collected
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 345 participants 343 participants 688 participants
5
(4 to 8)
5
(3 to 7)
5
(4 to 8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants 343 participants 688 participants
Female
168
  48.7%
154
  44.9%
322
  46.8%
Male
177
  51.3%
189
  55.1%
366
  53.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Participants With Level 3 Postoperative Hemorrhage
Hide Description 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.
Time Frame Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment With Ibuprofen Treatment With Acetaminophen
Hide Arm/Group Description:

Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.

Ibuprofen: 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.

Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.

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

Overall Number of Participants Analyzed 345 343
Measure Type: Count of Participants
Unit of Measure: Participants
10
   2.9%
4
   1.2%
Time Frame Adverse event data was collected during the 14-day postoperative follow-up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment With Ibuprofen Treatment With Acetaminophen
Hide Arm/Group Description

Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.

Ibuprofen: 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.

Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.

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

All-Cause Mortality
Treatment With Ibuprofen Treatment With Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/345 (0.00%)   0/343 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment With Ibuprofen Treatment With Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/345 (0.00%)   0/343 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment With Ibuprofen Treatment With Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/345 (0.00%)   0/343 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gillian Diercks, MD, MPH
Organization: Massachusetts Eye and Ear Infirmar
Phone: 617-573-3190
EMail: gillian_diercks@meei.harvard.edu
Publications:
Cardwell ME, Siviter G, Smith AF. Nonsteroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2010; (10): CD
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.
National Health Statistics Reports, Centers for Disease Control, Ambulatory Surgery in the United States, 2006. Number 11, January 28, 2009-Revised September 4, 2009. Available on the Web at www.cdc.gov/nchs.
Layout table for additonal information
Responsible Party: Christopher Hartnick, M.D., Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01605903     History of Changes
Other Study ID Numbers: 11-054H
First Submitted: May 23, 2012
First Posted: May 25, 2012
Results First Submitted: February 23, 2018
Results First Posted: March 26, 2018
Last Update Posted: April 24, 2018