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Prehospital Analgesia With Intra-Nasal Ketamine (PAIN-K)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02753114
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
British Columbia Emergency Health Services
Information provided by (Responsible Party):
Gary Andolfatto, University of British Columbia

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.


Condition or disease Intervention/treatment Phase
Pain Acute Pain Drug: Ketamine Drug: Normal Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prehospital Analgesia With Intra-Nasal Ketamine
Actual Study Start Date : November 6, 2017
Actual Primary Completion Date : May 24, 2018
Actual Study Completion Date : May 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intranasal Ketamine
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
Intranasal Ketamine administered via mucosal atomization device at 0.5 - 1 mg / kg IN.
Other Names:
  • Sandoz DIN 02246796
  • Ketalar

Placebo Comparator: Placebo
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
Intranasal Normal Saline administered via mucosal atomization device.
Other Name: Saline placebo




Primary Outcome Measures :
  1. Proportion experiencing 2-point or more pain score reduction at 30 minutes [ Time Frame: 30 minutes. ]
    The proportion of patients experiencing a 2-point or more reduction in NRS pain score at 30 minutes.


Secondary Outcome Measures :
  1. Proportion experiencing 2-point or more pain score reduction at 15 minutes [ Time Frame: 15 minutes ]
    The proportion of patients experiencing a 2-point or more reduction in NRS pain score at 15 minutes.

  2. The proportion of patients feeling "a lot better" or "moderately better" at 30 minutes post medication delivery or hospital at hospital arrival [ Time Frame: 30 minutes ]
    The proportion of patients feeling "a lot better" or "moderately better" at 30 minutes post medication delivery or hospital at hospital arrival

  3. The proportion of patients feeling "a lot better" or "moderately better" at 15 minutes. [ Time Frame: 15 minutes ]
    The proportion of patients feeling "a lot better" or "moderately better" at 15 minutes.

  4. The proportion of patients feeling "a lot better", "moderately better" or "a little better" at 15 minutes and at 30 minutes. [ Time Frame: 15 minutes, 30 minutes ]
    The proportion of patients feeling "a lot better", "moderately better" or "a little better" at 15 minutes and at 30 minutes.

  5. Adverse Events [ Time Frame: Every 15 minutes until care transferred to Emergency Department ]
    Incidence of adverse events.

  6. Patient Satisfaction [ Time Frame: At 30 minutes post analgesia administration. ]
    Patient satisfaction with analgesia provided using a ten point numeric rating scale anchored with 0 = "not at all satisfied" and 10 = "completely satisfied" on hospital arrival.

  7. Provider Satisfaction [ Time Frame: At 30 minutes post analgesia administration. ]
    Paramedic satisfaction with analgesia provided using a ten point numeric rating scale anchored with 0 = "not at all satisfied" and 10 = "completely satisfied" on hospital arrival.

  8. Median Nitrous Oxide Consumption [ Time Frame: At 30 minutes post analgesia administration. ]
    Median nitrous oxide consumption in each group will be recorded and compared.

  9. Median reduction in pain score at 15 minutes [ Time Frame: 15 minutes ]
    Median reduction in NRS pain score at 15 minutes

  10. Median reduction in pain score at 30 minutes [ Time Frame: 30 minutes ]
    Median reduction in NRS pain score at 30 minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753114


Locations
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Canada, British Columbia
British Columbia Emergency Health Services Station 249
Surrey, British Columbia, Canada, V3V 1Z2
Sponsors and Collaborators
University of British Columbia
British Columbia Emergency Health Services
Investigators
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Principal Investigator: Gary Andolfatto University of British Columbia
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gary Andolfatto, Assistant Professor, University of British Columbia Department of Emergency Medicine, University of British Columbia
ClinicalTrials.gov Identifier: NCT02753114    
Other Study ID Numbers: H16-00554
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gary Andolfatto, University of British Columbia:
Ketamine
Intranasal
Emergency Medical Services
Pain
Analgesia
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action