Intra-nasal Ketamine for Analgesia in the Emergency Department

NCT ID: NCT01686009

Last Updated: 2013-02-05

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-01-31

Brief Summary

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The provision of analgesia to patients in pain is a fundamental necessity of emergency department practice and is usually accomplished using IV opioids. However, significant barriers exist to the provision of timely analgesia by the IV route.

The use of the IN route for medication delivery provides an efficient and relatively painless mode of analgesia delivery. As well, ketamine is well-known to be an effective analgesic and to preserve cardiorespiratory function thus removing the necessity of physiologic monitoring that is obligatory when using opioids. The use of ketamine by the IN route provides a rapid, easy-administered and well-tolerated method for providing analgesia in the ED setting.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intra-nasal ketamine

0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary

Group Type EXPERIMENTAL

Intra-nasal ketamine

Intervention Type DRUG

Interventions

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Intra-nasal ketamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age 6 years or greater
* moderate or severe pain (VAS \>=50mm)

Exclusion Criteria

* history of allergy or intolerance to ketamine
* structural or functional nasal occlusion
* inability to understand the VAS
* Glasgow Coma Scale \< 15
* Systolic BP \> 180
* History of schizophrenia
* Clinical necessity for immediate IV access as judged by the treating physician
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Shore Health Research Foundation

UNKNOWN

Sponsor Role collaborator

Lions Gate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gary Andolfatto

Assistant Professor, University of British Columbia Department of Emergency Medicine; Attending Physician and Emergency Department Research Director, Lions Gate Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gary Andolfatto, MD

Role: PRINCIPAL_INVESTIGATOR

UBC Dept of EM; Lions Gate Hospital

Locations

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Lions Gate Hospital

North Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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UBC Dept of EM

Identifier Type: -

Identifier Source: org_study_id

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