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

NCT01605903 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 741

Last updated 2018-04-24

Study results available
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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

Interventions

DRUG

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.

DRUG

Acetaminophen

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

Sponsors & Collaborators

  • United States Naval Medical Center, San Diego

    collaborator FED

  • Brooke Army Medical Center

    collaborator FED

  • United States Naval Medical Center, Portsmouth

    collaborator FED

  • Madigan Army Medical Center

    collaborator FED

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Christopher J Hartnick, MD · Massachusetts Eye and Ear Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-03
Primary Completion
2017-02-15
Completion
2017-02-15

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01605903 on ClinicalTrials.gov