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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Treatment With Ibuprofen

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.

Treatment With Acetaminophen

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.


Participant Flow:   Overall Study
    Treatment With Ibuprofen   Treatment With Acetaminophen
STARTED   345   343 
COMPLETED   345   343 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Race and Ethnicity not collected

Reporting Groups
  Description
Treatment With Ibuprofen

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.

Treatment With Acetaminophen

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 Total of all reporting groups

Baseline Measures
   Treatment With Ibuprofen   Treatment With Acetaminophen   Total 
Overall Participants Analyzed 
[Units: Participants]
 345   343   688 
Age 
[Units: Years]
Median (Inter-Quartile Range)
     
Participants Analyzed   345   343   688 
   5 
 (4 to 8) 
 5 
 (3 to 7) 
 5 
 (4 to 8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   345   343   688 
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] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.


  Outcome Measures

1.  Primary:   Number of Participants With Level 3 Postoperative Hemorrhage   [ Time Frame: Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: Gillian Diercks, MD, MPH
Organization: Massachusetts Eye and Ear Infirmar
phone: 617-573-3190
e-mail: gillian_diercks@meei.harvard.edu


Publications:
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.


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