Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01169025
First received: July 7, 2010
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Trauma
Pain
Drug: Ketamine
Drug: Fentanyl

Study Type: Interventional
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
Official Title: Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change in NRS pain scores [ Time Frame: Assessed every 6 months. ] [ Designated as safety issue: No ]
    The primary outcome measure will be the change in NRS pain scores at ten minutes compared between the subjects administered ketamine and those administered fentanyl.


Secondary Outcome Measures:
  • Rates of adverse events [ Time Frame: Assessed every 6 months ] [ Designated as safety issue: Yes ]
    Includes comparisons of clinically significant complications between the two regimens: post-administration respiratory depression as evidenced by either a step up in supplemental oxygen requirements or the need for an airway intervention; episodes of hypotension or hypertension; significant tachycardia; new subjective participant complaints of dysphoria, anxiety, or agitation at any time following drug administration.

  • Change in NRS pain scores over time [ Time Frame: 24 months from start of enrollment ] [ Designated as safety issue: No ]
    Evaluate the differences in the slope of the NRS pain scores over time.

  • Amount of fentanyl required [ Time Frame: 24 months from start of enrollment ] [ Designated as safety issue: No ]
    Measurement of the total amount of fentanyl/kg body weight/minute of flight that was required to treat patients' pain.

  • Participant satisfaction [ Time Frame: 24 months from start of enrollment ] [ Designated as safety issue: No ]
    Overall research participant satisfaction with their level of pain relief at the end of the flight.

  • Pain Recall [ Time Frame: 24 months from start of enrollment ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: September 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
Subjects receive 0.3 mg/kg IV ketamine over 5 minutes and are evaluated every 10 minutes. Residual or recurring pain will be treated as needed with adjunctive open-label bolus dosing of IV fentanyl (1 mcg/kg) followed by repeat boluses as needed every 10 minutes during the flight. For this open-label portion of the flight, subjects are asked if they need additional pain medication every 10 minutes, unless an earlier, spontaneous request is made by the subject or the provider determines that more is needed. For the potential of rare ketamine side effects (dysphoria, anxiety, or agitation), 2 mg IV midazolam is given every 5 minutes as needed for any of these symptoms. Vital signs are measured continuously throughout the protocol. Blood pressure is measured at 5 minute intervals.
Drug: Ketamine
Subjects receive 0.3 mg/kg IV ketamine over 5 minutes and are evaluated every 10 minutes. Residual or recurring pain will be treated as needed with adjunctive open-label bolus dosing of IV fentanyl (1 mcg/kg) followed by repeat boluses as needed every 10 minutes during the flight. For this open-label portion of the flight, subjects are asked if they need additional pain medication every 10 minutes, unless an earlier, spontaneous request is made by the subject or the provider determines that more is needed. For the potential of rare ketamine side effects (dysphoria, anxiety, or agitation), 2 mg IV midazolam is given every 5 minutes as needed for any of these symptoms. Vital signs are measured continuously throughout the protocol. Blood pressure is measured at 5 minute intervals.
Other Names:
  • Ketalar
  • Ketamine
  • Ketamine hydrochloride
Active Comparator: Fentanyl
Subjects receive 1 mcg/kg IV fentanyl over 5 minutes. After first dose administration, subjects are evaluated every 10 minutes. Residual or recurring pain is treated as needed with adjunctive open-label bolus dosing of IV fentanyl (1 mcg/kg) followed by repeat boluses as needed every 10 minutes during the flight. For this open-label portion of the flight, flight nurses will query participants regarding their desire for additional pain medication every 10 minutes unless an earlier, spontaneous request is made by the participant or the provider determines that more is needed. Vital signs are measured continuously throughout the protocol. Blood pressure is measured at 5 minute intervals.
Drug: Fentanyl
Subjects receive 1 mcg/kg IV fentanyl over 5 minutes. After first dose administration, subjects are evaluated every 10 minutes. Residual or recurring pain is treated as needed with adjunctive open-label bolus dosing of IV fentanyl (1 mcg/kg) followed by repeat boluses as needed every 10 minutes during the flight. For this open-label portion of the flight, flight nurses will query participants regarding their desire for additional pain medication every 10 minutes unless an earlier, spontaneous request is made by the participant or the provider determines that more is needed. Vital signs are measured continuously throughout the protocol. Blood pressure is measured at 5 minute intervals.
Other Names:
  • Fentanil
  • Sublimaze
  • Actiq
  • Durogesic
  • Duragesic
  • Fentora
  • Onsolis
  • Instanyl

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169025

Locations
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Scott T Youngquist, MD, MS University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01169025     History of Changes
Other Study ID Numbers: IRB_00040229
Study First Received: July 7, 2010
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Analgesia
Pain

Additional relevant MeSH terms:
Analgesics
Ketamine
Fentanyl
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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
Adjuvants, Anesthesia
Narcotics
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 15, 2014