Intra-nasal Ketamine for Analgesia in the Emergency Department

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Intra-nasal ketamine

• Registration Number: NCT01686009
• Lead Sponsor: Lions Gate Hospital

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 available

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-17
• Study Start: 2012-10
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-03
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra-nasal ketamine	Intra-nasal ketamine	0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes.	30 minutes

Secondary Outcome Measures

Name	Time	Method
Median maximum reduction in VAS pain score achieved within 30 minutes	30 minutes
Median time required to achieve a 13-mm reduction in VAS pain score	1 hour
Vital signs changes (ETCO2, O2sat, HR, RR, BP)	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	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.

Trial Locations

Locations (1)

Lions Gate Hospital; 🇨🇦 North Vancouver, British Columbia, Canada