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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01169025
• Other study ID #: IRB_00040229
• Status: Withdrawn
• Phase: N/A
• First received: July 7, 2010
• Last updated: June 1, 2012
• Start date: September 2012
• Est. completion date: October 2014

Study information

• Verified date: June 2012
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pain
• Trauma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Utah Medical Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in NRS pain scores	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.	Assessed every 6 months.	No
Secondary	Rates of adverse events	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.	Assessed every 6 months	Yes
Secondary	Change in NRS pain scores over time	Evaluate the differences in the slope of the NRS pain scores over time.	24 months from start of enrollment	No
Secondary	Amount of fentanyl required	Measurement of the total amount of fentanyl/kg body weight/minute of flight that was required to treat patients' pain.	24 months from start of enrollment	No
Secondary	Participant satisfaction	Overall research participant satisfaction with their level of pain relief at the end of the flight.	24 months from start of enrollment	No
Secondary	Pain Recall	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.	24 months from start of enrollment	No