A Phase 4 interventional study of Dexamethasone and Analgesics in Pain, Postoperative, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Duke University · Phase 4, Interventional, and Supportive care
The purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy.
Patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid course of oral dexamethasone in addition opioids, acetaminophen,NSAIDs or 2) opioids/acetaminophen/NSAIDS alone. All drugs are prescribed per approved FDA labeling. Children between the ages of 4-17 will be considered for enrollment.
Participants (or with the aid of parents/legal guardian for subjects unable to complete on their own) will complete a diary twice a day to record pain medication administration and visual pain scale. Remaining steroid and opioid medication will be measured at the routine post-operative appointment that occurs 4 - 6 weeks following surgery.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 24 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
Drug: Dexamethasone · Drug: Analgesics
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Drug: Analgesics
dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.
standardization of post-operative analgesics (narcotics and non-narcotic medication). * Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses * Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication) * Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
Opioid Use (Number of Doses)
Measured by medication log and units remaining.
Time frame: 4 weeks post-op
Average Pain Score
Measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.
Time frame: 14 days post-op
Number of Participants With Post-operative Complications
Post-op re-admissions and emergency room visits.
Time frame: 30 days post-op
| Milestone | Dexamethasone Plus Analgesics | Analgesics Alone |
|---|---|---|
| Started | 16 | 8 |
| Completed | 14 | 7 |
| Not completed | 2 | 1 |
Measured by medication log and units remaining.
| doses | Dexamethasone Plus Analgesics | Analgesics Alone |
|---|---|---|
| Opioid Use (Number of Doses) | 11.5 ± 10.8 | 18.4 ± 8.4 |
Measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.
| score on a scale | Dexamethasone Plus Analgesics | Analgesics Alone |
|---|---|---|
| Average Pain Score | 3.1 ± 1.7 | 2.7 ± 0.8 |
Post-op re-admissions and emergency room visits.
| Participants | Dexamethasone Plus Analgesics | Analgesics Alone |
|---|---|---|
| Number of Participants With Post-operative Complications | 1 | 1 |
Collected over Up to 30 days post-op. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone Plus Analgesics | 0/16 (0%) | 0/16 (0%) | 12/16 (75%) |
| Analgesics Alone | 0/8 (0%) | 0/8 (0%) | 6/8 (75%) |
| Event | Dexamethasone Plus Analgesics | Analgesics Alone |
|---|---|---|
| Sleep Disturbance/InsomniaGeneral disorders | 11/16 | 5/8 |
| Nausea/VomitingGastrointestinal disorders | 5/16 | 3/8 |
| Emergency Room VisitGeneral disorders | 1/16 | 1/8 |
| BleedingInjury, poisoning and procedural complications | 2/16 | 1/8 |
| FeverGeneral disorders | 2/16 | 1/8 |
| ConstipationGastrointestinal disorders | 1/16 | 1/8 |
| Other - not specifiedGeneral disorders | 0/16 | 1/8 |
| Age, Continuous(years) | Dexamethasone Plus Analgesics | Analgesics Alone | Total |
|---|---|---|---|
| Mean | 8.8 ± 4.2 | 7.8 ± 2.7 | 8.5 ± 3.7 |
| Sex: Female, Male(Participants) | Dexamethasone Plus Analgesics | Analgesics Alone | Total |
|---|---|---|---|
| Female | 8 | 5 | 13 |
| Male | 8 | 3 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Dexamethasone Plus Analgesics | Analgesics Alone | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 12 | 7 | 19 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Race/Ethnicity, Customized(Participants) | Dexamethasone Plus Analgesics | Analgesics Alone | Total |
|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 0 | 0 |
| Race — Asian | 0 | 1 | 1 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Race — Black or African American | 4 | 2 | 6 |
| Race — White | 12 | 4 | 16 |
| Race — More than one race | 0 | 0 | 0 |
| Race — Other | 0 | 1 | 1 |
| Race — Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Dexamethasone Plus Analgesics | Analgesics Alone | Total |
|---|---|---|---|
| United States | 16 | 8 | 24 |
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Plan to share: No
Ran from Apr 2021 to primary completion in Dec 2023, 32 months.
Results were first posted in Dec 2024, 1 year after primary completion.
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Studies of the drug tested here: Dexamethasone