Safety Study of Post Tonsillectomy Ibuprofen Use in Adults

NCT ID: NCT01837810

Last Updated: 2013-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 810 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-05-31

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.

Detailed Description

Tonsillectomy is common procedure associated with significant post-operative pain typically managed by narcotic pain medication. Narcotics, however, can have inherent unwanted side effects such as respiratory depression. In fact, a recent U.S. Food and Drug Administration (FDA) warning has reported deaths from respiratory distress that were associated with use of codeine in children after tonsillectomy. Finding alternative pain management regimens therefore is essential in post-tonsillectomy care. Non-steroidal anti-inflammatory (NSAID) medications may provide an effective alternative to narcotics, but use of NSAIDs routinely after tonsillectomy has been limited due to concern for theoretical increased risk of post-operative bleeding, This is likely true for NSAIDs such as aspirin. NSAIDs such as ibuprofen, however, are believed to have no greater risk of bleeding than baseline, but this has not been proven. Recent, well-designed, prospective pediatric studies have demonstrated effective analgesia improvement with the addition of non-steroidal anti-inflammatory drugs such as ibuprofen to post-operative pain management regimens, and no increased rate of post-surgery bleeding. This has not adequately been studied in adults but could provide many patients significant pain relief in the post-operative period if it is shown to not increase post tonsillectomy hemorrhage rates, as already demonstrated in the pediatric population.

Conditions

Secondary Post Tonsillectomy Hemorrhage; Primary Post Tonsillectomy Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Ibuprofen

800mg ibuprofen every 8 hours prn pain.

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

800mg every 8 hours as needed for pain

Methylcellulose Powder

Subjects receive inert methylcellulose powder as placebo

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Ibuprofen

800mg every 8 hours as needed for pain

Intervention Type: DRUG

Other Intervention Names

Advil; Motrin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Madigan Army Medical Center

FED

Sponsor Role: collaborator

Tripler Army Medical Center

FED

Sponsor Role: collaborator

59th Medical Wing

FED

Sponsor Role: collaborator

Blanchfield Army Community Hospital

FED

Sponsor Role: collaborator

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Gregory R. Dion

MD, MS, CPT, MC, USA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory R Dion, MD, MS

Role: PRINCIPAL_INVESTIGATOR

San Antonio Military Medical Center

Locations

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status: RECRUITING

Wilford Hall Ambulatory Surgical Center

Lackland Air Force Base, Texas, United States

Site Status: NOT_YET_RECRUITING

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Gregory R Dion, MD, MS

Role: CONTACT

gregory.r.dion.mil@mail.mil

210-916-8040

Thomas J Willson, MD

Role: CONTACT

thomas.j.willson.mil@mail.mil

210-916-2367

Facility Contacts

Gregory R Dion, MD, MS

Role: primary

gregory.r.dion.mil@mail.mil

210-916-8040

Thomas J Willson, MD

Role: primary

thomas.j.willson.mil@mail.mil

210-916-2367

Del R Sloneker, MD

Role: primary

del.r.sloneker.mil@mail.mil

253-968-1420

Other Identifiers

384409

Identifier Type: -

Identifier Source: org_study_id