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Safety Study of Post Tonsillectomy Ibuprofen Use in Adults

NCT01837810 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 810

Last updated 2013-04-24

No results posted yet for this study

Summary

The purpose of this study is to determine if ibuprofen use after electrocautery tonsillectomy increases the post-tonsillectomy hemorrhage rate.

Hypothesis: Use of ibuprofen does not increase the post-tonsillectomy hemorrhage rate.

Primary outcome: Rate of tonsillar hemorrhage following adult tonsillectomy in those receiving narcotic pain medications plus ibuprofen compared to those receiving narcotics alone.

Secondary outcome: Determine whether ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), decreases post tonsillectomy pain, narcotic pain medication use, or cost of pain management.

Conditions

  • Secondary Post Tonsillectomy Hemorrhage
  • Primary Post Tonsillectomy Hemorrhage

Interventions

DRUG

Ibuprofen

800mg every 8 hours as needed for pain

Sponsors & Collaborators

  • Madigan Army Medical Center

    collaborator FED

  • Tripler Army Medical Center

    collaborator FED

  • 59th Medical Wing

    collaborator FED

  • Blanchfield Army Community Hospital

    collaborator FED

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Gregory R Dion, MD, MS · San Antonio Military Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01837810 on ClinicalTrials.gov