Intra-nasal Ketamine for Analgesia in the Emergency Department (INKA)

This study has been completed.

Sponsor:

Collaborator:

North Shore Health Research Foundation

Information provided by (Responsible Party):

Gary Andolfatto, Lions Gate Hospital

ClinicalTrials.gov Identifier:

NCT01686009

First received: September 12, 2012

Last updated: February 3, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2012

Last Updated Date

February 3, 2013

Start Date ^ICMJE

October 2012

Primary Completion Date

January 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes. [ Time Frame: 30 minutes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01686009 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Median maximum reduction in VAS pain score achieved within 30 minutes [ Time Frame: 30 minutes ]
Median time required to achieve a 13-mm reduction in VAS pain score [ Time Frame: 1 hour ]
Vital signs changes (ETCO2, O2sat, HR, RR, BP) [ Time Frame: 1 hour ]
Changes in vital signs will be recorded every 5 minutes for 30 minutes, then every 10 minutes for 30 minutes
Adverse effects as defined by SERSDA [ Time Frame: 1 hour ]
SERSDA (Side Effect Rating Scale for Dissociative Anaesthesia) includes: fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing, changes in vision, mood change, generalized discomfort, and hallucination.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intra-nasal Ketamine for Analgesia in the Emergency Department

Official Title ^ICMJE

Intra-nasal Ketamine for Analgesia in the Emergency Department

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Intra-nasal ketamine

Study Arms

Experimental: Intra-nasal ketamine

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

Intervention: Drug: Intra-nasal ketamine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

January 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

6 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01686009

Other Study ID Numbers ^ICMJE

UBC Dept of EM

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Gary Andolfatto, Lions Gate Hospital

Study Sponsor ^ICMJE

Lions Gate Hospital

Collaborators ^ICMJE

North Shore Health Research Foundation

Investigators ^ICMJE

Principal Investigator:

Gary Andolfatto, MD

UBC Dept of EM; Lions Gate Hospital

PRS Account

Lions Gate Hospital

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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