NCT01837810

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
810

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

3 years

First QC Date

April 18, 2013

Last Update Submit

April 22, 2013

Conditions

Secondary Post Tonsillectomy HemorrhagePrimary Post Tonsillectomy Hemorrhage

Keywords

Post tonsillectomy hemorrhagepost operative hemorrhagecomplicationstonsillectomy

Outcome Measures

Primary Outcomes (1)

  • clinically defined tonsil bleed rate (percentage)

    A post tonsillectomy hemorrhage/bleed, for the purposes of this study, is defined as a postoperative bleed requiring anything more than medicinal intervention (cauterization of any kind, suture, evaluation in operating room).

    2 weeks

Secondary Outcomes (4)

  • Hospital readmission rate (percentage)

    2 weeks

  • Subclinical (not requiring intervention) subjectively reported tonsil bleed rate (percentage)

    2 weeks

  • Pain scale rating

    2 Weeks

  • Nausea Scale

    2 weeks

Study Arms (2)

Ibuprofen

EXPERIMENTAL

800mg ibuprofen every 8 hours prn pain.

Drug: Ibuprofen

Methylcellulose Powder

PLACEBO COMPARATOR

Subjects receive inert methylcellulose powder as placebo

Interventions

IbuprofenDRUG

800mg every 8 hours as needed for pain

Also known as: Advil, Motrin
Ibuprofen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years old or older
  • Scheduled for tonsillectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

Wilford Hall Ambulatory Surgical Center

Lackland Air Force Base, Texas, 78236, United States

NOT YET RECRUITING

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Gregory R Dion, MD, MS

    San Antonio Military Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory R Dion, MD, MS

CONTACT

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

Thomas J Willson, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MS, CPT, MC, USA

Study Record Dates

First Submitted

April 18, 2013

First Posted

April 23, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations

US(3)