Tonsillitis
Conditions
Keywords
Tonsillectomy, Analgesia, Pain measurement, Celecoxib
Brief summary
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.
Detailed description
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.
Interventions
DRUGCelecoxib
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
DRUGPlacebo
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
Sponsors
Pfizer
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age at least 18 years * Indication for tonsillectomy (patients undergoing a tonsillectomy as a portion of additional surgical procedures will not be included) * Have the ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* History of bleeding disorders * History of liver or kidney dysfunction * History of allergy to sulfa containing medications * History of lactose intolerance * History of asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs * Women who are currently pregnant, nursing, or trying to conceive * History of allergy or intolerance to acetaminophen or hydrocodone * History of allergy to any COX-2 inhibitor, including celecoxib or rofecoxib. * PT, PTT, hemoglobin, or hematocrit values that are outside of institutional limits. * History of cardiovascular disease * Patients currently taking celecoxib
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Pain Score | day of procedure through post-operative day 10 | Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Activity Level | From operative day through 10 days post-operative | 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. |
| Acetaminophen Equivalent Use | From operative day through 10 days post-operative | Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals. |
| Incidence of Post-operative Hemorrhage | From operative day through 10 days post-operative | 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. |
| Total Morphine Equivalent | From operative day through 10 days post-operative | Participant reported mophine equivalent use |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib 200 mg Tablets Celecoxib 200 mg tablets
Celecoxib: 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 | 9 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm Placebo with same dosing schedule as the active comparator arm
Placebo: 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 | 8 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | discontinued intervention | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo With Same Dosing Schedule as the Active Comparator Arm | Celecoxib 200 mg Tablets | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 9 Participants | 17 Participants |
| Age, Continuous | 25.0 years STANDARD_DEVIATION 3.3 | 25.1 years STANDARD_DEVIATION 4.1 | 25.0 years STANDARD_DEVIATION 3.2 |
| Region of Enrollment United States | 8 participants | 9 participants | 17 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 9 | 2 / 6 |
| serious Total, serious adverse events | 0 / 9 | 0 / 6 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg Tablets | Self-reported Pain Score | Maximum pain, day 1 | 5.0 pain score (units on a scale) | Standard Error 0.6 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | maximum pain, averaged across days 2 to 4 | 5.1 pain score (units on a scale) | Standard Error 0.6 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | maximum pain, averaged across days 5 to 7 | 4.4 pain score (units on a scale) | Standard Error 0.6 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | maximum pain, averaged across days 8 to 10 | 3.6 pain score (units on a scale) | Standard Error 0.6 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | Average pain, day 1 | 6.1 pain score (units on a scale) | Standard Error 1 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | Average pain, averaged across days 2 to 4 | 6.2 pain score (units on a scale) | Standard Error 0.9 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | Average pain, averaged across days 5 to 7 | 6.1 pain score (units on a scale) | Standard Error 0.9 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | Average pain, averaged across days 8 to 10 | 4.9 pain score (units on a scale) | Standard Error 0.9 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | Pain with drinking, day 1 | 5.7 pain score (units on a scale) | Standard Error 0.9 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | Pain with drinking, averaged across days 2 to 4 | 5.4 pain score (units on a scale) | Standard Error 0.8 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | Pain with drinking, averaged across days 5 to 7 | 4.9 pain score (units on a scale) | Standard Error 0.8 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | Pain with drinking, averaged across days 8 to 10 | 3.9 pain score (units on a scale) | Standard Error 0.8 |
| Celecoxib 200 mg Tablets | Self-reported Pain Score | Activity, day 1 | 2.8 pain score (units on a scale) | Standard Error 0.9 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | Activity, day 1 | 4.5 pain score (units on a scale) | Standard Error 1 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | Pain with drinking, averaged across days 5 to 7 | 5.9 pain score (units on a scale) | Standard Error 0.7 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | Maximum pain, day 1 | 6.0 pain score (units on a scale) | Standard Error 0.7 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | Average pain, averaged across days 5 to 7 | 7.4 pain score (units on a scale) | Standard Error 0.8 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | maximum pain, averaged across days 2 to 4 | 6.0 pain score (units on a scale) | Standard Error 0.7 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | Pain with drinking, averaged across days 2 to 4 | 6.6 pain score (units on a scale) | Standard Error 0.7 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | maximum pain, averaged across days 5 to 7 | 5.9 pain score (units on a scale) | Standard Error 0.7 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | Average pain, averaged across days 8 to 10 | 5.7 pain score (units on a scale) | Standard Error 0.8 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | maximum pain, averaged across days 8 to 10 | 4.0 pain score (units on a scale) | Standard Error 0.7 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | Pain with drinking, averaged across days 8 to 10 | 4.1 pain score (units on a scale) | Standard Error 0.7 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | Average pain, day 1 | 7.3 pain score (units on a scale) | Standard Error 0.8 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | Pain with drinking, day 1 | 6.7 pain score (units on a scale) | Standard Error 0.8 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Pain Score | Average pain, averaged across days 2 to 4 | 7.6 pain score (units on a scale) | Standard Error 0.8 |
p-value: 0.674Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg Tablets | Acetaminophen Equivalent Use | Day 1 | 2074 mg | Standard Error 407 |
| Celecoxib 200 mg Tablets | Acetaminophen Equivalent Use | Average, days 2 to 4 | 2245 mg | Standard Error 356 |
| Celecoxib 200 mg Tablets | Acetaminophen Equivalent Use | Average, days 5 to 7 | 2028 mg | Standard Error 356 |
| Celecoxib 200 mg Tablets | Acetaminophen Equivalent Use | Average, days 8 to 10 | 1418 mg | Standard Error 356 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Acetaminophen Equivalent Use | Average, days 8 to 10 | 2483 mg | Standard Error 436 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Acetaminophen Equivalent Use | Day 1 | 3006 mg | Standard Error 498 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Acetaminophen Equivalent Use | Average, days 5 to 7 | 3610 mg | Standard Error 436 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Acetaminophen Equivalent Use | Average, days 2 to 4 | 2934 mg | Standard Error 436 |
p-value: 0.214Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Celecoxib 200 mg Tablets | Incidence of Post-operative Hemorrhage | 0 Participants |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Incidence of Post-operative Hemorrhage | 0 Participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg Tablets | Self-reported Activity Level | Day 1 | 2.8 Activity score (units on a scale) | Standard Error 0.9 |
| Celecoxib 200 mg Tablets | Self-reported Activity Level | Average, days 2 to 4 | 3.1 Activity score (units on a scale) | Standard Error 0.7 |
| Celecoxib 200 mg Tablets | Self-reported Activity Level | Average, days 5 to 7 | 5.4 Activity score (units on a scale) | Standard Error 0.7 |
| Celecoxib 200 mg Tablets | Self-reported Activity Level | Average, days 8 to 10 | 7.4 Activity score (units on a scale) | Standard Error 0.7 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Activity Level | Average, days 8 to 10 | 5.7 Activity score (units on a scale) | Standard Error 0.9 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Activity Level | Day 1 | 4.5 Activity score (units on a scale) | Standard Error 1 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Activity Level | Average, days 5 to 7 | 3.7 Activity score (units on a scale) | Standard Error 0.9 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Self-reported Activity Level | Average, days 2 to 4 | 4.1 Activity score (units on a scale) | Standard Error 0.9 |
p-value: 0.018Wilcoxon (Mann-Whitney)
Secondary
Total Morphine Equivalent
Participant reported mophine equivalent use
Time frame: From operative day through 10 days post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg Tablets | Total Morphine Equivalent | Day 1 | 28.9 mg | Standard Error 11.6 |
| Celecoxib 200 mg Tablets | Total Morphine Equivalent | Average, days 2 to 4 | 30.4 mg | Standard Error 9.6 |
| Celecoxib 200 mg Tablets | Total Morphine Equivalent | Average, days 5 to 7 | 27.8 mg | Standard Error 9.6 |
| Celecoxib 200 mg Tablets | Total Morphine Equivalent | Average, days 8 to 10 | 13.2 mg | Standard Error 9.6 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Total Morphine Equivalent | Average, days 8 to 10 | 38.3 mg | Standard Error 11.7 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Total Morphine Equivalent | Day 1 | 55.0 mg | Standard Error 14.2 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Total Morphine Equivalent | Average, days 5 to 7 | 69.7 mg | Standard Error 11.7 |
| Placebo With Same Dosing Schedule as the Active Comparator Arm | Total Morphine Equivalent | Average, days 2 to 4 | 72.4 mg | Standard Error 11.7 |
p-value: 0.036Wilcoxon (Mann-Whitney)