Recruiting

Ibuprofen

Sponsor:

Brooke Army Medical Center

Code:

NCT01837810

Conditions

Secondary Post Tonsillectomy Hemorrhage

Primary Post Tonsillectomy Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ibuprofen

Study Details

Brief 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

Study ID

NCT01837810

Start date

Apr, 2013

Status verified date

Apr, 2013

Completion date

May, 2016

Anticipated

Primary completion date

Apr, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults 18 years old or older
  • Scheduled for tonsillectomy

Exclusion Criteria:

  • Prisoners
  • Pregnancy
  • Allergy to ibuprofen
  • History of vasculopathy to include Lupus or Wegener's or Disseminated Intravascular Coagulation (DIC)
  • Any other bleeding disorder to include Von Willebrand Disease and others
  • Active Neoplasm of any kind
  • Tonsillectomy in combination with any sleep surgical procedure or palatal procedure

Study Design

Enrollment

810 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Ibuprofen

800mg ibuprofen every 8 hours prn pain.

placebo comparator: Methylcellulose Powder

Subjects receive inert methylcellulose powder as placebo

Interventions

Ibuprofen

800mg every 8 hours as needed for pain

Primary outcome measure

  • clinically defined tonsil bleed rate (percentage) [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Gregory R Dion, MD, MS

210-916-8040gregory.r.dion.mil@mail.mil

Thomas J Willson, MD

210-916-2367thomas.j.willson.mil@mail.mil

Locations

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Gregory R Dion, MD, MS

210-916-8040gregory.r.dion.mil@mail.mil

Principal Investigator:

Gregory R Dion, MD, MS

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Apr 24, 2013

Last verified

Apr, 2013

Keywords

  • Post tonsillectomy hemorrhage
  • post operative hemorrhage
  • complications
  • tonsillectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2013-04-24.