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NCT01267136 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
A Phase 4 study, sponsored by Children's Hospitals and Clinics of Minnesota.
- Completed
- Registry status
- Phase 4
- Development phase
- 84
- Enrollment target
NCT01267136 is a Phase 4 study that has completed, run by Children's Hospitals and Clinics of Minnesota. The registered enrollment target is 84 participants.
The verdict
NCT01267136, a Phase 4 study, has completed, sponsored by Children's Hospitals and Clinics of Minnesota.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 84 participants
- Enrollment target
Study Summary
Tonsillectomy is the most common pediatric surgical procedure performed in the US. The postoperative period can be particularly painful. Codeine (usually in mixed formulation with acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data questions its ability to provide optimal pain relief, while avoiding side effects, especially in the postoperative setting. Tramadol may be a better option for children in the postoperative setting due to its well-documented analgesic properties, low potential for side effects, and excellent safety profile. Seventy-two children scheduled to undergo tonsillectomy (with or without adenoidectomy) at Children's will be invited to participate in a randomized, prospective, double-blinded study to evaluate the efficacy and side effects of codeine with acetaminophen versus tramadol. 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 tramadol as compared with codeine/acetaminophen (the current practice standard) in a pediatric population. Hypotheses H1: Children who receive scheduled tramadol following tonsillectomy will report better pain control than children who receive scheduled codeine/acetaminophen. H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side effects than children who receive scheduled codeine/acetaminophen.
Interventions
- DRUG Codeine with acetaminophen
- DRUG Tramadol suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01267136
The ClinicalTrials.gov registry entry for NCT01267136 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 84 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 2 interventions - of which Codeine with acetaminophen is the first listed.
NCT01267136 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01267136 about?
NCT01267136 is a clinical study titled "A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy". Tonsillectomy is the most common pediatric surgical procedure performed in the US. The postoperative period can be particularly painful. Codeine (usually in mixed formulation with acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data questions its ability to provide...
What is the current status of trial NCT01267136?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2011-01. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01267136?
The interventions under investigation include: Codeine with acetaminophen (DRUG), Tramadol suspension (DRUG).
Who is sponsoring clinical trial NCT01267136?
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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