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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 is a Phase 4 study that has completed, run by HealthPartners Institute. The registered enrollment target is 77 participants.

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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.

Interventions

  • DRUG Ketamine
  • DRUG Morphine

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2012-12
Est. Completion 2015-06
Phase Phase 4

Sponsor

HealthPartners Institute

146 total trials

What the Registry Record Tells You About NCT01951963

The ClinicalTrials.gov registry entry for NCT01951963 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HealthPartners Institute, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.

NCT01951963 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.