Prehospital Analgesia With Intra-Nasal Ketamine

NCT02753114 | Completed Phase 4 DMC

• 1 other identifier: H16-00554
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Acute painful conditions make-up a large proportion of pre-hospital transports in British Columbia (BC) yet Basic Life Support (BLS) paramedics have limited options to provide analgesia and therefore adequate and timely pain relief is often significantly delayed. Inhaled nitrous oxide is commonly used as a pre-hospital analgesic and is considered "usual care" for pre-hospital providers in BC, but its utility in severe pain is uncertain. Moreover, nitrous oxide is limited in its effectiveness by a short duration of action, nausea, vomiting, and the necessity for patient cooperation. IN Ketamine has been shown to provide rapid, easily-administered, and well-tolerated analgesia in many settings. The investigators believe that the addition of IN ketamine to usual care with nitrous oxide inhalation for adults experiencing moderate to severe intensity acute pain in the pre-hospital setting will result in improved pain severity, improved patient-reported comfort, and improved patient satisfaction.

Conditions

Pain; Acute Pain

Keywords

Ketamine; Intranasal; Emergency Medical Services; Pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• Proportion experiencing 2-point or more pain score reduction at 30 minutes

  The proportion of patients experiencing a 2-point or more reduction in NRS pain score at 30 minutes.

  30 minutes.

Secondary Outcomes (10)

• Proportion experiencing 2-point or more pain score reduction at 15 minutes

  15 minutes

• The proportion of patients feeling "a lot better" or "moderately better" at 30 minutes post medication delivery or hospital at hospital arrival

  30 minutes

• The proportion of patients feeling "a lot better" or "moderately better" at 15 minutes.

  15 minutes

• The proportion of patients feeling "a lot better", "moderately better" or "a little better" at 15 minutes and at 30 minutes.

  15 minutes, 30 minutes

• Adverse Events

  Every 15 minutes until care transferred to Emergency Department

Study Arms (2)

Intranasal Ketamine

EXPERIMENTAL

Ketamine dosing will be weight-based as follows: 30mg of IN ketamine for patients weighing 50 kg or less; 50 mg of IN ketamine for patients weighing 50 kg to 100 kg; and 75 mg of IN ketamine for patients weighing greater than 100 kg (i.e. 0.5 mg/kg to 1.0 mg/kg of intranasal ketamine). Syringes containing ketamine will be prepared from the intravenous formulation of Ketamine (50 mg / ml) solution (Sandoz; DIN 02246796) and stored in pre-filled 5 ml syringes. Ketamine will be administered to patients through a mucosal atomization device. One-half of the pre-specified volume will be administered into each nare. No repeat doses will be administered.

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Syringes containing normal saline will be prepared such that the volume of normal saline in 5 ml syringes matches that of the ketamine for each of the weight based groups previously specified in the Treatment Arm Description. Syringes containing normal saline will also be labeled "Study Drug". The normal saline will also be administered to patients through a mucosal atomization device. One-half of the pre-specified volume will be administered into each nare. No repeat doses of placebo will be administered.

Drug: Normal Saline

Interventions

Ketamine DRUG

Intranasal Ketamine administered via mucosal atomization device at 0.5 - 1 mg / kg IN.

Also known as: Sandoz DIN 02246796, Ketalar

Intranasal Ketamine

Normal Saline DRUG

Intranasal Normal Saline administered via mucosal atomization device.

Also known as: Saline placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients who have an acute painful condition, as determined by the Emergency Health Services attendant
• A pain score of 5 or greater (signifying moderate or severe pain)
• Desire for analgesia when queried.

You may not qualify if:

• Less than 18 years of age.
• Previous hypersensitivity, intolerance or allergy to ketamine
• Chest pain
• Altered mental status
• Inability self-report pain score
• Pregnancy
• Nasal occlusion
• Systolic Blood Pressure \< 90 mm Hg
• Requiring immediate attention of the paramedic
• Ineligible to receive inhaled nitrous oxide as per BC EHS protocols

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Emergency Health Services: collaborator

Study Sites (1)

British Columbia Emergency Health Services Station 249

Surrey, British Columbia, V3V 1Z2, Canada

Location

Related Publications (35)

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• Andolfatto G, Innes K, Dick W, Jenneson S, Willman E, Stenstrom R, Zed PJ, Benoit G. Prehospital Analgesia With Intranasal Ketamine (PAIN-K): A Randomized Double-Blind Trial in Adults. Ann Emerg Med. 2019 Aug;74(2):241-250. doi: 10.1016/j.annemergmed.2019.01.048. Epub 2019 Mar 27.

  PMID: 30926189 DERIVED

Related Links

• British Columbia Ambulance Service information page.

MeSH Terms

Conditions

Pain; Acute Pain; Agnosia

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Gary Andolfatto

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, University of British Columbia Department of Emergency Medicine

Study Record Dates

• First Submitted: April 16, 2016
• First Posted: April 27, 2016
• Study Start: November 6, 2017
• Primary Completion: May 24, 2018
• Study Completion: May 24, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Locations

CA (1)