Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Intra-nasal ketamine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-nasal Ketamine for Analgesia in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Lions Gate Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median maximum reduction in VAS pain score achieved within 30 minutes [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Median time required to achieve a 13-mm reduction in VAS pain score [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Vital signs changes (ETCO2, O2sat, HR, RR, BP) [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 40
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-nasal ketamine
0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary
Drug: Intra-nasal ketamine

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686009

Locations
Canada, British Columbia
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
Sponsors and Collaborators
Lions Gate Hospital
North Shore Health Research Foundation
Investigators
Principal Investigator: Gary Andolfatto, MD UBC Dept of EM; Lions Gate Hospital
  More Information

No publications provided

Responsible Party: Gary Andolfatto, Assistant Professor, University of British Columbia Department of Emergency Medicine; Attending Physician and Emergency Department Research Director, Lions Gate Hospital, Lions Gate Hospital
ClinicalTrials.gov Identifier: NCT01686009     History of Changes
Other Study ID Numbers: UBC Dept of EM
Study First Received: September 12, 2012
Last Updated: February 3, 2013
Health Authority: Canada: Health Canada

Keywords provided by Lions Gate Hospital:
pain
analgesia
ketamine
intranasal
emergency

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Ketamine
Analgesics
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014