Intra-nasal Ketamine for Analgesia in the Emergency Department

NCT01686009 | Completed Phase 4

• 1 other identifier: UBC Dept of EM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain; analgesia; ketamine; intranasal; emergency

Outcome Measures

Primary Outcomes (1)

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

  30 minutes

Secondary Outcomes (4)

• 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

• Adverse effects as defined by SERSDA

  1 hour

Study Arms (1)

Intra-nasal ketamine

EXPERIMENTAL

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

Drug: Intra-nasal ketamine

Interventions

Intra-nasal ketamine DRUG

Intra-nasal ketamine

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lions Gate Hospital: lead
• North Shore Health Research Foundation: collaborator

Study Sites (1)

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

MeSH Terms

Conditions

Pain; Agnosia; Emergencies

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Gary Andolfatto, MD

  UBC Dept of EM; Lions Gate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, University of British Columbia Department of Emergency Medicine; Attending Physician and Emergency Department Research Director, Lions Gate Hospital

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 17, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

CA (1)