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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: Clinical Trial Phase 4 study, sponsored by Children's Hospitals and Clinics of Minnesota.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To compare the efficacy of scheduled tramadol + PRN ibuprofen/tramadol vs. scheduled tramadol + scheduled gabapentin + PRN ibuprofen/tramadol for pain management during the post-tonsillectomy recovery period. Efficacy will be measured through daily collection of three pain scores (FACES or numeric; 0-10 rating): "pain right now," "typical pain over the past 24 hours," and "worst pain in the past 24 hours." Efficacy will also be measured daily with: 1) the Parents' Postoperative Pain Measure, 2)
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 |
Why NCT02076893 stopped before completion
NCT02076893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02076893 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02076893's enrollment target sits among peer trials
64 1098th of 2000 higher than 895 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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