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NCT01951963 · ClinicalTrials.gov registry record · Phase 4
Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
A Phase 4 study, sponsored by HealthPartners Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 77
- Enrollment target
NCT01951963: Completed Phase 4 study, sponsored by HealthPartners Institute.
NCT01951963 is a Phase 4 study that has completed, run by HealthPartners Institute. The registered enrollment target is 77 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01951963, a Phase 4 study, has completed, sponsored by HealthPartners Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 77 participants
- Enrollment target
Study Summary
The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (ED) compared to a group of patients who receive morphine alone for pain management. Patients are randomized to receive either a single bolus of ketamine (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be accomplished using morphine. Patient, family member, and research staff pain scores will be recorded, until 3 hours post study medication administration. Family members are contacted via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be calculated for up to 3 hours post study medication administration and compared between the ketamine and morphine groups.
Primary Outcome
All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results.
Interventions
- DRUG Ketamine
- DRUG Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
What the finished NCT01951963 record still lists
NCT01951963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT01951963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01951963 about?
NCT01951963 is a clinical study titled "Sub-dissociative Ketamine for the Management of Acute Pediatric Pain". The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (...
What is the current status of trial NCT01951963?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 77 participants. The study started on 2012-12. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01951963?
The interventions under investigation include: Ketamine (DRUG), Morphine (DRUG).
Who is sponsoring clinical trial NCT01951963?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01951963's enrollment target sits among peer trials
77 989th of 2000 higher than 1,007 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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