Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
Information source: University of Utah
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Trauma; Pain
Intervention: Ketamine (Drug); Fentanyl (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: University of Utah Official(s) and/or principal investigator(s): Scott T Youngquist, MD, MS, Principal Investigator, Affiliation: University of Utah
Summary
Often, patients transported by aeromedical systems do not receive enough medication to
control and relieve their pain. The purpose of this study is to determine if pain treatment
with intravenous (IV) ketamine is a better way to treat aeromedical patients' pain than the
current treatment practices.
Clinical Details
Official title: Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Change in NRS pain scores
Secondary outcome: Rates of adverse eventsChange in NRS pain scores over time Amount of fentanyl required Participant satisfaction Pain Recall
Detailed description:
Specific Aims: The aim of this study is to determine the efficacy, side effects and safety
of sub-dissociative doses of ketamine in controlling acute traumatic pain in patients
transported by an aeromedical system when compared to standard doses of fentanyl.
Research Hypothesis: Aeromedical transport patients with acute pain treated with intravenous
ketamine show a clinically significant difference in mean numeric rating scale (NRS) pain
scores as compared to those treated with fentanyl and show no increase in adverse events.
Background and Significance: Treatment of acute pain in aeromedical transport patients is
important. Treatment may be limited by real or perceived concerns regarding analgesic side
effects including sedation, loss of airway maintenance, and negative hemodynamic
consequences. Ketamine used in sub-dissociative doses has strong analgesic properties while
maintaining protective airway reflexes and demonstrating minimal adverse hemodynamic
effects. It has been suggested as an ideal pre-hospital analgesic. Current literature
regarding its use in the pre-hospital environment is limited.
Experimental Design: This prospective, double-blind, randomized trial compares 0. 3 mg/kg of
intravenous (IV) ketamine to 1 mcg/kg of IV fentanyl in adult aeromedical transport patients
who require pain control. The primary outcome measure will be the change in NRS pain scores
at ten minutes compared between the two groups. Secondary endpoints will include rates of
adverse events, differences in the slope of NRS scores over time, the total amount of
fentanyl/kg body weight/minute of flight required, overall research participant satisfaction
with their level of pain relief at the end of the flight, and the subjective ranking of pain
recall in comparison to other aspects of the patient's overall episode of care
(pre-hospital, emergency department, inpatient, and post-discharge care), as measured at 30
days.
Data Analysis: Categorical variables will be analyzed using chi-square and Fisher's exact
test. Means of normally distributed variables will be compared using Student's t-test, and
distributions of non-normally distributed variables will be compared using Mann-Whitney U.
Bayesian generalized linear mixed modeling will be employed to model the time-dependent
change in NRS scores between intervention groups while accounting for the autocorrelation
inherent in a repeated measures design. SAS statistical software (SAS v. 9. 2, Cary, NC) and
WinBUGS software will be used for all analyses.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age > 18 years
- Moderate to severe acute, traumatic pain (self-reported NRS > 5)
- Ability to provide informed consent in English
- Flight destination to University of Utah Medical Center
Exclusion Criteria:
- Inability to use the NRS pain rating scale
- Historical or acute myocardial infarction or ischemia
- Ongoing hypertensive emergency
- Unconsciousness
- Allergic reaction to ketamine
- Increased intracranial or intraocular pressure
- Known pregnancy
- Prisoner
Locations and Contacts
University of Utah Medical Center, Salt Lake City, Utah 84132, United States
Additional Information
Starting date: September 2012
Last updated: June 1, 2012
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