Back to resultsIntranasal Ketamine for Acute Traumatic Pain
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Intranasal Ketamine, Analgesia, Trauma, Morphine, Mass Casualty
Eligibility Criteria
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.
Sites / Locations
- Tel Aviv Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
IN Ketamine
IM Morphine
IV Morphine
Arm Description
A single administration of 1 mg/kg ketamine hydrochloride delivered in an intranasal route using an atomizer
A single administration of 0.15 mg/kg intramuscular morphine
A single administration of 0.1 mg/kg slow intravascular bolus of morphine.
Outcomes
Primary Outcome Measures
Effectiveness of intranasal ketamine in decreasing pain intensity [patient assessed - VAS pain score]
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.
Secondary Outcome Measures
adverse effects [Opiate Related Symptom Distress Scale]
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]
patients were asked to provide subjective comments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02817477
Brief Title
Intranasal Ketamine for Acute Traumatic Pain
Official Title
Intranasal Ketamine for Acute Traumatic Pain in the Emergency Department: A Prospective, Randomized Clinical Trial of Efficacy and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Intranasal Ketamine, Analgesia, Trauma, Morphine, Mass Casualty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IN Ketamine
Arm Type
Experimental
Arm Description
A single administration of 1 mg/kg ketamine hydrochloride delivered in an intranasal route using an atomizer
Arm Title
IM Morphine
Arm Type
Active Comparator
Arm Description
A single administration of 0.15 mg/kg intramuscular morphine
Arm Title
IV Morphine
Arm Type
Active Comparator
Arm Description
A single administration of 0.1 mg/kg slow intravascular bolus of morphine.
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
Delivered intranasally using an atomizer
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Delivered either as an IM injection or a slow IV bolus
Primary Outcome Measure Information:
Title
Effectiveness of intranasal ketamine in decreasing pain intensity [patient assessed - VAS pain score]
Description
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.
Time Frame
1 hour post administration
Secondary Outcome Measure Information:
Title
adverse effects [Opiate Related Symptom Distress Scale]
Description
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.
Time Frame
1 hour post administration
Title
patient satisfaction [Interview]
Description
patients were asked to provide subjective comments
Time Frame
1 hour post administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pinchas Halpern, MD
Organizational Affiliation
Tel Aviv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27829367
Citation
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. doi: 10.1186/s12873-016-0107-0.
Results Reference
derived
Learn more about this trial
Intranasal Ketamine for Acute Traumatic Pain
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