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

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ClinicalTrials.gov Identifier: NCT01169025
Recruitment Status : Withdrawn
First Posted : July 23, 2010
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):
University of Utah

Tracking Information
First Submitted Date  ICMJE July 7, 2010
First Posted Date  ICMJE July 23, 2010
Last Update Posted Date June 4, 2012
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
Change in NRS pain scores [ Time Frame: Assessed every 6 months. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
  • Rates of adverse events [ Time Frame: Assessed every 6 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
Official Title  ICMJE Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Trauma
  • Pain
Intervention  ICMJE
  • 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 hydrochloride
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ketamine
  • 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.
    Intervention: Drug: Fentanyl
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 1, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2010)
150
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01169025
Other Study ID Numbers  ICMJE IRB_00040229
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Utah
Original Responsible Party Scott T. Youngquist/Principal Investigator, Department of Surgery Assistant Professor, University of Utah School of Medicine, Department of Surgery, Division of Emergency Medicine
Current Study Sponsor  ICMJE University of Utah
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott T Youngquist, MD, MS University of Utah
PRS Account University of Utah
Verification Date June 2012

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