Intranasal Ketamine for Acute Traumatic Pain

NCT02817477 | Completed Phase 4

• 1 other identifier: 0312-11-TLV
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. Objective: To elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine. Methods: A single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe acute traumatic pain (≥80mm on 100mm Visual Analog Scale \[VAS\]) were randomized to receive either 1.0mg/kg IN ketamine, 0.1mg/kg IV MO or 0.15mg/kg IM MO. Pain relief and adverse effects were recorded for 1 hour post-administration. Primary Outcomes: The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by "time-to-onset" (defined as a ≥15mm pain decrease on VAS), as well as time to and degree of maximal pain reduction.

Conditions

Acute Pain

Keywords

Intranasal Ketamine, Analgesia, Trauma, Morphine, Mass Casualty

Outcome Measures

Primary Outcomes (1)

• Effectiveness of intranasal ketamine in decreasing pain intensity [patient assessed - VAS pain score]

  Time to achieve a clinically meaningful pain reduction was defined as the first time-point at which the patient reported 15mm of pain reduction or more. Maximal pain reduction was defined as the lowest VAS score reported by the patient over the course of follow-up. Time to maximal pain reduction was defined as the time at which the patient has the lowest VAS score over the course of the hour follow-up.

  1 hour post administration

Secondary Outcomes (2)

• adverse effects [Opiate Related Symptom Distress Scale]

  1 hour post administration

• patient satisfaction [Interview]

  1 hour post administration

Study Arms (3)

IN Ketamine

EXPERIMENTAL

A single administration of 1 mg/kg ketamine hydrochloride delivered in an intranasal route using an atomizer

Drug: Ketamine Hydrochloride

IM Morphine

ACTIVE COMPARATOR

A single administration of 0.15 mg/kg intramuscular morphine

Drug: Morphine

IV Morphine

ACTIVE COMPARATOR

A single administration of 0.1 mg/kg slow intravascular bolus of morphine.

Drug: Morphine

Interventions

Ketamine Hydrochloride DRUG

Delivered intranasally using an atomizer

IN Ketamine

Morphine DRUG

Delivered either as an IM injection or a slow IV bolus

IM Morphine; IV Morphine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Any analgesia received within the prior 3 hours, allergic sensitivity to morphine or ketamine, a large meal ingested within the previous hour, pregnancy, deviated nasal septum or trauma to the nose, and a history of a psychiatric condition. Despite evidence that ketamine does not exacerbate intracranial hemorrhage in patients with head trauma, patients with head injury complaining of loss of consciousness, dizziness, vomiting, or nausea were excluded as well.

Sponsors & Collaborators

• Tel Aviv Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Related Publications (1)

• Shimonovich S, Gigi R, Shapira A, Sarig-Meth T, Nadav D, Rozenek M, West D, Halpern P. Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety. BMC Emerg Med. 2016 Nov 9;16(1):43. doi: 10.1186/s12873-016-0107-0.

  PMID: 27829367 DERIVED

MeSH Terms

Conditions

Acute Pain; Agnosia; Wounds and Injuries

Interventions

Ketamine; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Pinchas Halpern, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Emergency Department, Tel Aviv Medical Center

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 30, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)