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OpenTrials
Completed

NCT Number: NCT01686009

Intra-nasal Ketamine for Analgesia in the Emergency Department

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.

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Key information

Conditions

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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-nasal ketamine

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. Median maximum reduction in VAS pain score achieved within 30 minutes

    Time frame: 30 minutes

  2. Median time required to achieve a 13-mm reduction in VAS pain score

    Time frame: 1 hour

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Lions Gate Hospital

Other

Collaborators

  • North Shore Health Research Foundation

Registry information

Acronym: INKA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 17, 2012
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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