Secondary Post Tonsillectomy HemorrhageNCT01837810
Safety Study of Post Tonsillectomy Ibuprofen Use in Adults
A study testing Ibuprofen in people with Secondary Post Tonsillectomy Hemorrhage and Primary Post Tonsillectomy Hemorrhage, run by Brooke Army Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Post Tonsillectomy Hemorrhage, Primary Post Tonsillectomy Hemorrhage
- What is being tested?
- Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 810 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years old or older
- Scheduled for tonsillectomy
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Gregory R Dion, MD, MS, 210-916-8040, gregory.r.dion.mil@mail.mil
Gregory R Dion, MD, MS
- Not yet recruiting
Wilford Hall Ambulatory Surgical Center
Lackland Air Force Base, Texas, 78236
Thomas J Willson, MD, 210-916-2367, thomas.j.willson.mil@mail.mil
Thomas J Willson, MD
- Not yet recruiting
Madigan Army Medical Center
Tacoma, Washington, 98431
Del R Sloneker, MD, 253-968-1420, del.r.sloneker.mil@mail.mil
Del R Sloneker, MD
About this study
Official title: NSAID Post-Tonsillectomy Hemorrhage: A Randomized, Double-Blinded Controlled Noninferiority Trial
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.
Read the 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.
- Being tested
- Ibuprofen
- Keywords
- Post tonsillectomy hemorrhage, post operative hemorrhage, complications, tonsillectomy
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Advil, Motrin
800mg every 8 hours as needed for pain
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | 800mg ibuprofen every 8 hours prn pain. Receives: Drug: Ibuprofen |
| Methylcellulose Powder | Placebo comparator | Subjects receive inert methylcellulose powder as placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Secondary outcomes (4)
Hospital readmission rate (percentage)
Measured: 2 weeks
Subclinical (not requiring intervention) subjectively reported tonsil bleed rate (percentage)
Subjects will report on followup survey if they had post operative oral bleeding more than streaked blood in their spit for which they did not go to the hospital or clinic for treatment of.
Measured: 2 weeks
Pain scale rating
Subjects will answer a visual analog scale (VAS) Pain scale for days 1, 3, 7, and 14 after tonsillectomy.
Measured: 2 Weeks
Nausea Scale
Subjects will answer a VAS nausea scale for days 1, 3, and 7 after tonsillectomy.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Post Tonsillectomy HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 810 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Madigan Army Medical Center, Tripler Army Medical Center, 59th Medical Wing, Blanchfield Army Community Hospital
- Responsible party
- Principal investigator, Gregory R. Dion, Brooke Army Medical Center
- Investigators
- Gregory R Dion, MD, MS, Principal investigator, San Antonio Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837810
- Sponsor's protocol ID
- 384409
- Status last verified
- Apr 2013
- First submitted
- 18 Apr 2013
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSAID Post-Tonsillectomy Hemorrhage: A Randomized, Double-Blinded Controlled Noninferiority Trial
- ClinicalTrials.gov ID
- NCT01837810
- Acronym / sponsor ID
- 384409
- Keywords
- Post tonsillectomy hemorrhage, post operative hemorrhage, complications, tonsillectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 810 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- Madigan Army Medical Center, Tripler Army Medical Center, 59th Medical Wing, Blanchfield Army Community Hospital
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: Ibuprofen800mg ibuprofen every 8 hours prn pain. |
| Methylcellulose Powder | Placebo comparator | –Subjects receive inert methylcellulose powder as placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18 years old or older
- Scheduled for tonsillectomy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: Advil, Motrin800mg every 8 hours as needed for pain | Drug | Ibuprofen |
Primary outcome
clinically defined tonsil bleed rate (percentage)
Time frame: 2 weeks
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).
4 secondary outcomes
Hospital readmission rate (percentage)
Time frame: 2 weeks
Subclinical (not requiring intervention) subjectively reported tonsil bleed rate (percentage)
Time frame: 2 weeks
Pain scale rating
Time frame: 2 Weeks
Nausea Scale
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
Related trials for Secondary Post Tonsillectomy Hemorrhage
Not yet recruitingObservational study
The Impact of Tonsillectomy Techniques on Secondary Tonsillectomy Bleeding
Post-Tonsillectomy Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory R Dion, MD, MS principal investigator
San Antonio Military Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen in people with Secondary Post Tonsillectomy Hemorrhage and Primary Post Tonsillectomy Hemorrhage, run by Brooke Army Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregory R Dion, MD, MS (210-916-8040, gregory.r.dion.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinically defined tonsil bleed rate (percentage) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.