Intra-nasal Ketamine for Analgesia in the Emergency Department

Pain Clinical Trial

— INKA  

Official title:

Intra-nasal Ketamine for Analgesia in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686009
• Other study ID #: UBC Dept of EM
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2012
• Last updated: February 3, 2013
• Start date: October 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Lions Gate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Pain

Intervention

Drug:
• Intra-nasal ketamine

Locations

Country	Name	City	State
Canada	Lions Gate Hospital	North Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Lions Gate Hospital	North Shore Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes.		30 minutes	No
Secondary	Median maximum reduction in VAS pain score achieved within 30 minutes		30 minutes	No
Secondary	Median time required to achieve a 13-mm reduction in VAS pain score		1 hour	No
Secondary	Vital signs changes (ETCO2, O2sat, HR, RR, BP)	Changes in vital signs will be recorded every 5 minutes for 30 minutes, then every 10 minutes for 30 minutes	1 hour	Yes
Secondary	Adverse effects as defined by SERSDA	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.	1 hour	Yes