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History of Changes for Study: NCT02866071
Intranasal Ketamine as an Adjunct to Fentanyl for the Prehospital Treatment of Acute Traumatic Pain
Latest version (submitted July 1, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 9, 2016 None (earliest Version on record)
2 May 11, 2017 Study Status, Oversight and IPDSharing
3 October 18, 2017 Recruitment Status, Study Status, Contacts/Locations, Eligibility, Study Design and Study Description
4 January 22, 2018 Study Status, Eligibility and Study Description
5 November 8, 2018 Study Status, Study Description and Sponsor/Collaborators
6 March 20, 2019 Study Status
7 January 2, 2020 Study Status
8 July 1, 2021 Study Status
Comparison Format:

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Study NCT02866071
Submitted Date:  August 9, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: McMullan Ketamine
Brief Title: Intranasal Ketamine as an Adjunct to Fentanyl for the Prehospital Treatment of Acute Traumatic Pain
Official Title: Intranasal Ketamine as an Adjunct to Fentanyl for the Prehospital Treatment of Acute Traumatic Pain
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2016
Overall Status: Not yet recruiting
Study Start: October 2016
Primary Completion: December 2019 [Anticipated]
Study Completion: December 2020 [Anticipated]
First Submitted: August 5, 2016
First Submitted that
Met QC Criteria:
August 9, 2016
First Posted: August 15, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 9, 2016
Last Update Posted: August 15, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Jason McMullan
Responsible Party: Sponsor-Investigator
Investigator: Jason McMullan
Official Title: Director, Fellowship in EMS Medicine; Associate Director-Research, Division of EMS; Associate Professor of Emergency Medicine
Affiliation: University of Cincinnati
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

STUDY SYNOPSIS Objectives The primary objective is to estimate the proportion of subjects who report clinically important reductions in pain score (defined as 2 points on a 0-10 verbal numerical rating scale) after receiving fentanyl (50mcg) with or without intranasal (IN) ketamine (50mg) prior to hospital arrival for the treatment of acute traumatic pain.

Design and Outcomes This is a prospective, randomized, placebo-controlled single-site clinical trial. The primary outcome variable is reduction of reported pain of at least 2 points (on the 0-10 Verbal Numerical Rating Scale1,2) when comparing the pretreatment pain score to the pain score obtained upon reassessment 30 minutes after medication administration. Secondary outcomes include: reduction of reported pain at Emergency Department (ED) arrival; the incidence of adverse events; additional opiate requirements prior to ED arrival and in the first three hours of ED care; development of chronic pain (measured by the Brief Pain Inventory,3) or post-traumatic stress disorder (measured by the PTSD Checklist for DSM-54) and overall satisfaction with life (measured by the Satisfaction With Life Scale5) at 90-days after injury.

Interventions and Duration Adults who qualify for prehospital pain treatment under paramedic standing orders will be screened for inclusion and, if eligible, will undergo an IRB-approved consent process concurrent with receiving 50mcg fentanyl (IV or IN per current standard practice). Consenting subjects will be 1:1 randomized to receive either 50mg IN ketamine or IN placebo. Pain will be rated on a 0-10 scale by the subject prior to treatment, at 30 minutes following treatment, at ED arrival, and at 30 minute intervals for the first three hours of their ED care. Additional pain medications given prior to hospital arrival and within the first three hours of ED care will also be recorded. The primary outcome will be reduction in baseline pain between the pretreatment measurement and 30 minutes after medication administration. Overall satisfaction with life and symptoms of PTSD and chronic pain will be assessed before hospital disposition (in-person) and via phone follow-up at 90-days (+/- 14 days) after injury.

Sample size and Power The Investigators consider a two point reduction in pain to be clinically significant, and thus will compare the proportion of subjects achieving a two point reduction in pain at 30 minutes post-medication administration between the treatment group and the control group. Sample size considerations are based on this primary analysis. To test the hypothesis that the proportion of those treated with fentanyl alone that have at least a 2 point reduction in their pain will be lower than the proportion of those treated with the combination of fentanyl and single-dose ketamine who have a 2 point reduction in their pain, the investigators will use a chi-square test (or the Fisher's Exact Test if appropriate). An intent to treat approach will be used. It is expected the response rate in the two groups will be 40% and 60%, respectively. These estimates are based on the response rates in a study comparing pain management efficacy between subjects treated with morphine alone and morphine plus ketamine. With this magnitude of effect, a sample size of 97 per group will have 80% power to detect the difference between the two groups when the critical level of significance is set to 5%. To allow for subject drop-out, protocol deviations, and missing outcome data, the investigators plan to enroll an additional 15% in each arm, for a total of 224 subjects.

Detailed Description:
Open or close this module Conditions
Conditions: Acute Traumatic Pain
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 225 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Ketamine
50mg IN Ketamine Hydrochloride
Drug: Ketamine Hydrochloride
50mg IN Ketamine Hydrochloride
Placebo Comparator: Placebo
50mg IN placebo
Drug: Placebo-Comparator
50mg IN Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Reduction in Pain
[ Time Frame: between pre-treatment EMS assessment (baseline) and at 30-minutes post-treatment ]

reduction in reported pain of two or more points based on the Verbal Numerical Rating Scale.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Subjects must be experiencing pain due to acute trauma (i.e. extremity deformity, tourniquet placement, or severe burns).
  • A Verbal Numerical Rating Scale pain score ≥7 prior to medication administration.
  • Age: ≥18 through 65 years (i.e. subjects must have had their 18th birthday, but not had their 66th birthday).
  • Systolic blood pressure ≥100mmHg.
  • Transported directly from the scene of injury to the Emergency Department at University of Cincinnati Medical Center by a participating EMS agency.
  • English-speaking.

Exclusion Criteria:

  • Subject reported allergy to morphine, fentanyl, or ketamine.
  • EMS treatment with ketamine (any), morphine (any), or >50mcg of fentanyl prior to enrollment.
  • Inter-facility transfers.
  • Prisoners or those in police custody.
  • Known or suspected pregnancy.
  • Paramedic clinical concern of acute agitation or psychosis.
  • Pain medication not needed in judgment of prehospital provider.
  • Altered level of consciousness, mental status change, or suspected head injury.
  • Paramedic clinical concern of circulatory shock.
  • Inability to provide Verbal Numerical Rating Scale.
  • Facial injury or suspicion of nasal bone fracture.
  • Paramedic judgment that subject cannot consent due to underlying cognitive impairment.
Open or close this module Contacts/Locations
Central Contact Person: Jason McMullan, MD
Telephone: 513-585-8962
Email: mcmulljo@ucmail.uc.edu
Central Contact Backup: Emily Werff
Telephone: 513-558-2953
Email: emily.werff@uc.edu
Locations: United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Contact:Contact: Emily Werff 513-558-2953 emily.werff@uc.edu
Contact:Principal Investigator: Jason McMullan, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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