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NCT02866071 · ClinicalTrials.gov registry record · Phase 3
Intranasal Ketamine as an Adjunct to Fentanyl for the Prehospital Treatment of Acute Traumatic Pain
A Phase 3 study of Acute Traumatic Pain, sponsored by Jason McMullan.
- Active
- Registry status
- Phase 3
- Development phase
- 224
- Enrollment target
- 1
- Study location
NCT02866071 is a Phase 3 study of Acute Traumatic Pain that is active but no longer recruiting, run by Jason McMullan. The registered enrollment target is 224 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02866071, a Phase 3 study of Acute Traumatic Pain, is active but no longer recruiting, sponsored by Jason McMullan.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 224 participants
- Enrollment target
- 1
- Study location
Study Summary
STUDY SYNOPSIS Objectives The primary objective is to estimate the proportion of subjects who report clinically important reductions in pain score (defined as 2 points on a 0-10 verbal numerical rating scale) after receiving a single dose of fentanyl (per local standard) with or without intranasal (IN) ketamine (50mg) prior to hospital arrival for the treatment of acute traumatic pain. Design and Outcomes This protocol describes two linked studies conducted as a prospective, randomized, placebo-controlled single-site clinical trial. The primary study has a primary outcome variable of reduction of reported pain of at least 2 points (on the 0-10 Verbal Numerical Rating Scale1,2) when comparing the pretreatment pain score to the pain score obtained upon reassessment 30 minutes after medication administration; secondary outcomes of the primary trial include reduction of reported pain at Emergency Department (ED) arrival; the incidence of adverse events; additional opiate requirements prior to ED arrival and in the first three hours of ED care. The secondary study explores secondary outcomes including: development of chronic pain (measured by the Brief Pain Inventory,3) or post-traumatic stress disorder (measured by the PTSD Checklist for DSM-54) and overall satisfaction with life (measured by the Satisfaction With Life Scale5) at 90-days after injury. Interventions and Duration Adult men who qualify for prehospital pain treatment under paramedic standing orders will be screened for inclusion and will undergo informed consent for the primary trial. After ED arrival, subjects who consented for the primary trial will be approached for inclusion in the secondary trial. Prehospital consent for primary trial enrollment and study drug administration will occur concurrent with receiving a single dose of fentanyl (IV, IM or IN per current standard practice). Consenting subjects will be 1:1 randomized to receive either 50mg IN ketamine or IN saline placebo. Pain will be rated o
Conditions Studied
Interventions
- DRUG Ketamine Hydrochloride
- DRUG Placebo-Comparator
Study Locations (1)
Ohio
- University of Cincinnati Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2017-10-03 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02866071
The ClinicalTrials.gov registry entry for NCT02866071 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jason McMullan, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Traumatic Pain appearing as the primary indexed condition, and to 2 interventions - of which Ketamine Hydrochloride is the first listed.
NCT02866071 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT02866071 about?
NCT02866071 is a clinical study titled "Intranasal Ketamine as an Adjunct to Fentanyl for the Prehospital Treatment of Acute Traumatic Pain". STUDY SYNOPSIS Objectives The primary objective is to estimate the proportion of subjects who report clinically important reductions in pain score (defined as 2 points on a 0-10 verbal numerical rating scale) after receiving a single dose of fentanyl (per local standard) with or without intranasal (...
What is the current status of trial NCT02866071?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 224 participants. The study started on 2017-10-03. Estimated completion is 2022-12-31.
What conditions does trial NCT02866071 study?
This clinical trial studies the following conditions: Acute Traumatic Pain.
What interventions are being tested in trial NCT02866071?
The interventions under investigation include: Ketamine Hydrochloride (DRUG), Placebo-Comparator (DRUG).
Who is sponsoring clinical trial NCT02866071?
This trial is sponsored by Jason McMullan, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02866071 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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