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Intranasal Ketamine for Acute Traumatic Pain

NCT ID: NCT02817477

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Pain

Keywords

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Intranasal Ketamine, Analgesia, Trauma, Morphine, Mass Casualty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IN Ketamine

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

Group Type EXPERIMENTAL

Ketamine Hydrochloride

Intervention Type DRUG

Delivered intranasally using an atomizer

IM Morphine

A single administration of 0.15 mg/kg intramuscular morphine

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Delivered either as an IM injection or a slow IV bolus

IV Morphine

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

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Delivered either as an IM injection or a slow IV bolus

Interventions

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Ketamine Hydrochloride

Delivered intranasally using an atomizer

Intervention Type DRUG

Morphine

Delivered either as an IM injection or a slow IV bolus

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel Aviv Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Prof. Pinchas (Pinny) Halpern MD

Chair, Emergency Department, Tel Aviv Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pinchas Halpern, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

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Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 27829367 (View on PubMed)

Other Identifiers

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0312-11-TLV

Identifier Type: -

Identifier Source: org_study_id