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NCT02076893 · ClinicalTrials.gov registry record · Phase 4
Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen
A Phase 4 study, sponsored by Children's Hospitals and Clinics of Minnesota.
- Terminated
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
NCT02076893 is a Phase 4 study that was terminated before completion, run by Children's Hospitals and Clinics of Minnesota. The registered enrollment target is 64 participants.
The verdict
NCT02076893, a Phase 4 study, was terminated before completion, sponsored by Children's Hospitals and Clinics of Minnesota.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
Study Summary
Tonsillectomy is the most common pediatric surgical procedure performed in the US, with over 530,000 procedures performed annually in children under 15 years (Baugh et al., 2011). The postoperative period can be particularly painful. A recent clinical consensus acknowledges there is no standard analgesic protocol, and calls for further research comparing postoperative pain medications (Baugh et al., 2011). Tramadol was found to be as effective as codeine with few reported side effects in a recent double-blinded, controlled trial conducted by the investigators at Children's Hospitals and Clinics (CHC), and it is currently being prescribed in the postoperative setting. However, despite its effectiveness for pain control, there were some children that continued to report pain during the 10-day follow-up period. In response, the investigators will conduct a randomized, double-blinded controlled trial to determine whether or not adding scheduled gabapentin to a scheduled tramadol + "as needed" (PRN) ibuprofen regimen provides better pain control than tramadol + ibuprofen PRN alone during the post-tonsillectomy period. Using a 10-day take-home diary, caregivers will be asked to record daily information about their child's postoperative pain and other core outcomes and domains as recommended in the recent consensus statement put forth by the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the efficacy and side effects associated with adding scheduled gabapentin to a postoperative pain management protocol in a pediatric population.
Interventions
- DRUG Placebo
- DRUG Ibuprofen
- DRUG Tramadol
- DRUG gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2014-03 |
| Est. Completion | 2017-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02076893
The ClinicalTrials.gov registry entry for NCT02076893 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospitals and Clinics of Minnesota, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02076893 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02076893 about?
NCT02076893 is a clinical study titled "Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen". Tonsillectomy is the most common pediatric surgical procedure performed in the US, with over 530,000 procedures performed annually in children under 15 years (Baugh et al., 2011). The postoperative period can be particularly painful. A recent clinical consensus acknowledges there is no standard anal...
What is the current status of trial NCT02076893?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2014-03. Estimated completion is 2017-02.
What interventions are being tested in trial NCT02076893?
The interventions under investigation include: Placebo (DRUG), Ibuprofen (DRUG), Tramadol (DRUG), gabapentin (DRUG).
Who is sponsoring clinical trial NCT02076893?
This trial is sponsored by Children's Hospitals and Clinics of Minnesota, which has 31 total clinical trials registered on ClinicalTrials.gov.
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