A Phase 2 interventional study of Celecoxib and Placebo in Tonsillitis, sponsored by University of Iowa. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by University of Iowa · Phase 2, Interventional, and Supportive care
The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces post-operative narcotic use.
To test this hypothesis, the study is placebo controlled (sugar pill). Half of the participants will receive a sugar pill, half will not.
All participants will receive the standard post-operative pain medications.
We ask participants to log the amount of medications they use daily, and the amount of pain they have each day. It is hoped that celecoxib will reduce the amount of post-operative pain medication needed.
Post-tonsillectomy pain is typically controlled through narcotic medications, such as Lortab elixir. Despite its standard use, this pain control is typically not as effective as a non-steroidal anti-inflammatory medication (NSAID). The problem with using NSAIDs for post-tonsillectomy operative pain is the significant increased risk of rebleeding.
Celecoxib is an NSAID that is a COX-2 inhibitor; the drug is designed to act as an NSAID without the increased risk of rebleeding or hemorrhage.
This study is a double blind, randomized study; neither the study participant or the study investigator knows if the participant is receiving celecoxib or a placebo (sugar pill). The blinded list is maintained by the research pharmacists and can be unblinded when needed (such as in an emergency).
Participants begin taking the study medication the night before surgery and continue through 10 days post-operative. Participants are asked to complete a journal that catalogs the amount of standard post-operative medications taken, the amount of pain experienced, and any other comments.
Participants are contacted by phone at 5 and 10 days post-op.
Study participation ends at the standard 3-week post-operative check-up.
102 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 18 is below the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Celecoxib 200 mg tablets
Drug: Celecoxib
Placebo with same dosing schedule as the active comparator arm
Drug: Placebo
Celecoxib 200 mg capsule 1. capsule the night before surgery 2. capsules the morning of surgery 1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery
Also known as: Celebrex
Placebo capsule 1. capsule the night before surgery 2. capsules the morning of surgery 1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery
Self-reported Pain Score
Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily.
Time frame: day of procedure through post-operative day 10
Self-reported Activity Level
Activity level, reported by participant utilizing a 10-point ordinal scale (0 = no activity, 10 = return to normal activities). Activity level was measured was collected once daily.
Time frame: From operative day through 10 days post-operative
Acetaminophen Equivalent Use
Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals.
Time frame: From operative day through 10 days post-operative
Incidence of Post-operative Hemorrhage
The incidence of post-operative hemorrhage, defined as post-operative bleeding requiring medical intervention or hospitalization during the 10 day post-operative follow-up period.
Time frame: From operative day through 10 days post-operative
Total Morphine Equivalent
Participant reported mophine equivalent use
Time frame: From operative day through 10 days post-operative
| Milestone | Celecoxib as Experimerimental Intervention | Placebo Control, Active Comparator |
|---|---|---|
| Started | 9 | 8 |
| Completed | 9 | 6 |
| Not completed | 0 | 2 |
| Withdrew: Discontinued intervention | 0 | 2 |
Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily.
| pain score (units on a scale) | Celecoxib 200 mg Tablets | Placebo With Same Dosing Schedule as the Active Comparator Arm |
|---|---|---|
| Maximum pain, day 1 | 5.0 ± 0.6 | 6.0 ± 0.7 |
| maximum pain, averaged across days 2 to 4 | 5.1 ± 0.6 | 6.0 ± 0.7 |
| maximum pain, averaged across days 5 to 7 | 4.4 ± 0.6 | 5.9 ± 0.7 |
| maximum pain, averaged across days 8 to 10 | 3.6 ± 0.6 | 4.0 ± 0.7 |
| Average pain, day 1 | 6.1 ± 1.0 | 7.3 ± 0.8 |
| Average pain, averaged across days 2 to 4 | 6.2 ± 0.9 | 7.6 ± 0.8 |
| Average pain, averaged across days 5 to 7 | 6.1 ± 0.9 | 7.4 ± 0.8 |
| Average pain, averaged across days 8 to 10 | 4.9 ± 0.9 | 5.7 ± 0.8 |
| Pain with drinking, day 1 | 5.7 ± 0.9 | 6.7 ± 0.8 |
| Pain with drinking, averaged across days 2 to 4 | 5.4 ± 0.8 | 6.6 ± 0.7 |
| Pain with drinking, averaged across days 5 to 7 | 4.9 ± 0.8 | 5.9 ± 0.7 |
| Pain with drinking, averaged across days 8 to 10 | 3.9 ± 0.8 | 4.1 ± 0.7 |
| Activity, day 1 | 2.8 ± 0.9 | 4.5 ± 1.0 |
Activity level, reported by participant utilizing a 10-point ordinal scale (0 = no activity, 10 = return to normal activities). Activity level was measured was collected once daily.
| Activity score (units on a scale) | Celecoxib as Experimerimental Intervention | Placebo Control, Active Comparator |
|---|---|---|
| Day 1 | 2.8 ± 0.9 | 4.5 ± 1.0 |
| Average, days 2 to 4 | 3.1 ± 0.7 | 4.1 ± 0.9 |
| Average, days 5 to 7 | 5.4 ± 0.7 | 3.7 ± 0.9 |
| Average, days 8 to 10 | 7.4 ± 0.7 | 5.7 ± 0.9 |
Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals.
| mg | Celecoxib as Experimerimental Intervention | Placebo Control, Active Comparator |
|---|---|---|
| Day 1 | 2074 ± 407 | 3006 ± 498 |
| Average, days 2 to 4 | 2245 ± 356 | 2934 ± 436 |
| Average, days 5 to 7 | 2028 ± 356 | 3610 ± 436 |
| Average, days 8 to 10 | 1418 ± 356 | 2483 ± 436 |
The incidence of post-operative hemorrhage, defined as post-operative bleeding requiring medical intervention or hospitalization during the 10 day post-operative follow-up period.
| Participants | Celecoxib 200 mg Tablets | Placebo With Same Dosing Schedule as the Active Comparator Arm |
|---|---|---|
| Incidence of Post-operative Hemorrhage | 0 | 0 |
Participant reported mophine equivalent use
| mg | Celecoxib as Experimerimental Intervention | Placebo Control, Active Comparator |
|---|---|---|
| Day 1 | 28.9 ± 11.6 | 55.0 ± 14.2 |
| Average, days 2 to 4 | 30.4 ± 9.6 | 72.4 ± 11.7 |
| Average, days 5 to 7 | 27.8 ± 9.6 | 69.7 ± 11.7 |
| Average, days 8 to 10 | 13.2 ± 9.6 | 38.3 ± 11.7 |
Collected over 3 weeks postoperatively. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Celecoxib as Experimerimental Intervention | — | 0/9 (0%) | 1/9 (11.1%) |
| Placebo Control, Active Comparator | — | 0/6 (0%) | 2/6 (33.3%) |
| Event | Celecoxib as Experimerimental Intervention | Placebo Control, Active Comparator |
|---|---|---|
| Vomiting, grade 1Gastrointestinal disorders | 1/9 | 2/6 |
| Dehydration, grade 2Metabolism and nutrition disorders | 0/9 | 2/6 |
| Dysphagia, grade 2Gastrointestinal disorders | 0/9 | 1/6 |
| Age, Categorical(Participants) | Celecoxib 200 mg Tablets | Placebo With Same Dosing Schedule as the Active Comparator Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 8 | 17 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Celecoxib 200 mg Tablets | Placebo With Same Dosing Schedule as the Active Comparator Arm | Total |
|---|---|---|---|
| Mean | 25.1 ± 4.1 | 25.0 ± 3.3 | 25.0 ± 3.2 |
| Sex: Female, Male(Participants) | Celecoxib 200 mg Tablets | Placebo With Same Dosing Schedule as the Active Comparator Arm | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 1 | 1 | 2 |
| Region of Enrollment(participants) | Celecoxib 200 mg Tablets | Placebo With Same Dosing Schedule as the Active Comparator Arm | Total |
|---|---|---|---|
| United States | 9 | 8 | 17 |
Plan to share: Yes — Data will be uploaded through clinicaltrials.gov data tables
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University of Iowa