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Intranasal Ketamine for Acute Traumatic Pain

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ClinicalTrials.gov Identifier: NCT02817477
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Pinchas (Pinny) Halpern MD, Tel Aviv Medical Center

Tracking Information
First Submitted Date  ICMJE June 27, 2016
First Posted Date  ICMJE June 29, 2016
Last Update Posted Date June 30, 2016
Study Start Date  ICMJE September 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
Effectiveness of intranasal ketamine in decreasing pain intensity [patient assessed - VAS pain score] [ Time Frame: 1 hour post administration ]
Time to achieve a clinically meaningful pain reduction was defined as the first time-point at which the patient reported 15mm of pain reduction or more. Maximal pain reduction was defined as the lowest VAS score reported by the patient over the course of follow-up. Time to maximal pain reduction was defined as the time at which the patient has the lowest VAS score over the course of the hour follow-up.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2016)
Effectiveness of intranasal ketamine in decreasing pain intensity [ Time Frame: 1 hour post administration ]
Time to achieve a clinically meaningful pain reduction was defined as the first time-point at which the patient reported 15mm of pain reduction or more. Maximal pain reduction was defined as the lowest VAS score reported by the patient over the course of follow-up. Time to maximal pain reduction was defined as the time at which the patient has the lowest VAS score over the course of the hour follow-up.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
  • adverse effects [Opiate Related Symptom Distress Scale] [ Time Frame: 1 hour post administration ]
    Adverse effects were recorded at the end of one hour using the 'Opiate Related Symptom Distress Scale' and included measurements of the presence, frequency, intensity and disruptiveness of 12 common opiate side-effects. Among these were nausea, vomiting, urinary retention, constipation, difficulty concentrating, dizziness, confusion, and others.
  • patient satisfaction [Interview] [ Time Frame: 1 hour post administration ]
    patients were asked to provide subjective comments
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2016)
  • adverse effects [ Time Frame: 1 hour post administration ]
    Adverse effects were recorded at the end of one hour using the 'Opiate Related Symptom Distress Scale' and included measurements of the presence, frequency, intensity and disruptiveness of 12 common opiate side-effects. Among these were nausea, vomiting, urinary retention, constipation, difficulty concentrating, dizziness, confusion, and others.
  • patient satisfaction [ Time Frame: 1 hour post administration ]
    patients were asked to provide subjective comments
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Ketamine for Acute Traumatic Pain
Official Title  ICMJE Intranasal Ketamine for Acute Traumatic Pain in the Emergency Department: A Prospective, Randomized Clinical Trial of Efficacy and Safety
Brief Summary

Introduction: Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting.

Objective: To elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine.

Methods: A single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe acute traumatic pain (≥80mm on 100mm Visual Analog Scale [VAS]) were randomized to receive either 1.0mg/kg IN ketamine, 0.1mg/kg IV MO or 0.15mg/kg IM MO. Pain relief and adverse effects were recorded for 1 hour post-administration.

Primary Outcomes: The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by "time-to-onset" (defined as a ≥15mm pain decrease on VAS), as well as time to and degree of maximal pain reduction.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE
  • Drug: Ketamine Hydrochloride
    Delivered intranasally using an atomizer
  • Drug: Morphine
    Delivered either as an IM injection or a slow IV bolus
Study Arms  ICMJE
  • Experimental: IN Ketamine
    A single administration of 1 mg/kg ketamine hydrochloride delivered in an intranasal route using an atomizer
    Intervention: Drug: Ketamine Hydrochloride
  • Active Comparator: IM Morphine
    A single administration of 0.15 mg/kg intramuscular morphine
    Intervention: Drug: Morphine
  • Active Comparator: IV Morphine
    A single administration of 0.1 mg/kg slow intravascular bolus of morphine.
    Intervention: Drug: Morphine
Publications * Shimonovich S, Gigi R, Shapira A, Sarig-Meth T, Nadav D, Rozenek M, West D, Halpern P. Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety. BMC Emerg Med. 2016 Nov 9;16(1):43.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2016)
90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients aged 18-70 years, with mild to moderate blunt trauma (sustained in road, workplace and home accidents) causing moderate to severe pain (≥ 80mm score on a 100mm Visual Analog Scale=VAS) were eligible for participation in the study. Inclusion criteria also included a Glasgow Coma Score (GCS) of 15, body weight of 50-110 kg, systolic blood pressure of 90-160 mmHg, heart rate <100 bpm. Patients were also required to have an American Society of Anesthesiologists (ASA) score of 1 or 2, deny head injury, and deny regular use or use of opiates.

Exclusion Criteria:

Any analgesia received within the prior 3 hours, allergic sensitivity to morphine or ketamine, a large meal ingested within the previous hour, pregnancy, deviated nasal septum or trauma to the nose, and a history of a psychiatric condition. Despite evidence that ketamine does not exacerbate intracranial hemorrhage in patients with head trauma, patients with head injury complaining of loss of consciousness, dizziness, vomiting, or nausea were excluded as well.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02817477
Other Study ID Numbers  ICMJE 0312-11-TLV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Prof. Pinchas (Pinny) Halpern MD, Tel Aviv Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tel Aviv Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pinchas Halpern, MD Tel Aviv Medical Center
PRS Account Tel Aviv Medical Center
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP