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IN Sub-Dissociative Ketamine vs IN Fentanyl

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ClinicalTrials.gov Identifier: NCT02521415
Recruitment Status : Unknown
Verified September 2016 by Stacy Reynolds, Atrium Health.
Recruitment status was:  Recruiting
First Posted : August 13, 2015
Last Update Posted : October 3, 2016
Sponsor:
Collaborators:
Carolinas Trauma Network Research Group
Charlotte, Houston, Milwaukee Prehospital Emergency Research Nodal Center-CHaMP-ERNC
Information provided by (Responsible Party):
Stacy Reynolds, Atrium Health

Tracking Information
First Submitted Date  ICMJE August 5, 2015
First Posted Date  ICMJE August 13, 2015
Last Update Posted Date October 3, 2016
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
Primary outcome: proportion of participants with minor side effects and significant adverse events [ Time Frame: 60 minutes ]
We will conclude that such a study is NOT feasible if we observe a rate of side effects for ketamine that exceeds fentanyl by three-fold or event rate of 5% or more for ketamine-related SAEs.
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2015)
proportion of participants with minor side effects and significant adverse events [ Time Frame: 6 hours ]
We will conclude that such a study is NOT feasible if we observe a rate of side effects for ketamine that exceeds fentanyl by three-fold or event rate of 5% or more for ketamine-related SAEs.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2016)
Secondary outcome: total dose of opioid pain medication in morphine equivalents/kg/hour [ Time Frame: participants will be followed during the emergency department length of stay, estimated to average 6 hours ]
Compare the total dose of opioid pain medication in morphine equivalents/kg/hour required during the ED evaluation of children with suspected forearm fractures after randomization and treatment with IN ketamine or IN fentanyl.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2015)
total dose of narcotic pain medication in morphine equivalents/kg/hour [ Time Frame: participants will be followed during the emergency department length of stay, estimated to average 6 hours ]
Compare the total dose of narcotic pain medication in morphine equivalents/kg/hour required during the ED evaluation of children with suspected forearm fractures after randomization and treatment with IN ketamine or IN fentanyl.
Current Other Pre-specified Outcome Measures
 (submitted: March 28, 2016)
  • Exploratory Outcome: reduction in age appropriate pain scale scores [ Time Frame: 20 minutes ]
    difference in the reduction of the pain scale scores at 20 minutes.
  • Secondary safety outcome: proportion of patients with types of adverse events [ Time Frame: 6 hours ]
    Compare the frequency of types of adverse events over 6-hours among children randomized to receive either intranasal sub-dissociative ketamine (IN ketamine) or intranasal fentanyl (IN fentanyl) for pain control in the emergency department.
Original Other Pre-specified Outcome Measures
 (submitted: August 11, 2015)
  • reduction in age appropriate pain scale scores [ Time Frame: 20 minutes ]
    difference in the reduction of the pain scale scores at 20 minutes.
  • proportion of patients with types of adverse events [ Time Frame: 6 hours ]
    Compare the frequency of types of adverse events over 6-hours among children randomized to receive either intranasal sub-dissociative ketamine (IN ketamine) or intranasal fentanyl (IN fentanyl) for pain control in the emergency department.
 
Descriptive Information
Brief Title  ICMJE IN Sub-Dissociative Ketamine vs IN Fentanyl
Official Title  ICMJE Randomized Controlled Trial of Intranasal Ketamine Compared to Intranasal Fentanyl for Analgesia in Children With Suspected, Isolated Extremity Fractures in the Pediatric Emergency Department
Brief Summary

This single center, randomized control, double blind trial will prospectively examine the feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for pain control in the pediatric emergency department setting. The investigators hypothesize that IN ketamine may provide a safe and effective alternative to IN fentanyl for children with suspected, isolated extremity fractures.

Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.

Detailed Description

Intranasal medications are commonly used in place of parenteral opioids in children. IN fentanyl is the most commonly used intranasal analgesic medication in the pediatric population with demonstrated safety and efficacy comparable to IV fentanyl and IV morphine. IN ketamine, at sub-dissociative doses, offers similar safety and efficacy to IN fentanyl and the additional advantage of potentially reducing the total use of opioid agents during the emergency department visit. Ketamine is easily stored and has a wide therapeutic window with an extremely low risk of cardiorespiratory complications. This study will compare the safety and efficacy of IN ketamine to IN fentanyl in children with suspected, isolated extremity fractures in the pediatric emergency department.

The primary aim of the study is to examine the feasibility of future protocol expansion. The investigators will conclude that additional studies are NOT feasible if the observed rate of side effects for ketamine that exceeds fentanyl by three-fold or event rate of 5% or more for ketamine-related SAEs. The primary aim of the study will compare the frequency of adverse events over 6-hours among children randomized to receive either intranasal sub-dissociative ketamine (IN ketamine) or intranasal fentanyl (IN fentanyl) for pain control in the emergency department. The exploratory aim of the study will compare the efficacy of intranasal ketamine to intranasal fentanyl as measured by a reduction in age appropriate pain scale scores over 2-hours. The secondary aim of the study will compare the total dose of opioid pain medication in morphine equivalents/kg/hour required during the ED evaluation of children with suspected, isolated extremity fractures after randomization and treatment with IN ketamine or IN fentanyl.

Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.

All participants will be premedicated with acetaminophen or ibuprofen and baseline data, including pain level, will be collected. The trial consists of two treatment arms. (IN ketamine 1 mg/kg or IN fentanyl 1.5 mcg/kg). Randomization will follow a 1:1 ratio, with approximately 40 per group. Randomization will be stratified by ages 3-10 and 11-17. The participants will be assessed by a research coordinator for adverse events every 5 minutes using an adverse events checklist for the first fifteen minutes post study medication administration and every 30 minutes for the first two hours after drug administration. The vital signs and pain scale assessment will be repeated every 10 minutes for the first 30 minutes and then every 30 minutes for the first two hours after drug administration. A final assessment will be made 6 hours after the last dose of study drug or at discharge from the ED to assess for late side effects or adverse events. Study medication may be repeated times one at a reduced dose after 20 minutes when the full effects of the first dose are known. The decision to administer additional study medication (0.5 mg/kg ketamine or 0.75 mcg/kg fentanyl ) will at be at the discretion of the treating physician. Should a second dose of study medication be required, a new schedule of patient assessments will commence following the same schedule as for the first dose. Participant assessments will continue until the 2 hour endpoint is reached from the time of the last drug administration, with a final assessment at 6 hours after the last dose of study drug or at discharge from the ED to assess for late side effects or adverse events.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bone Fracture
Intervention  ICMJE
  • Drug: ketamine
    intranasal (IN) sub-dissociative ketamine (1mg/kg)
    Other Name: intranasal pain medication
  • Drug: fentanyl
    Intranasal (IN) fentanyl (1.5 micrograms/kg)
    Other Name: intranasal pain medication
  • Drug: ibuprofen or acetaminophen
    10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention
Study Arms  ICMJE
  • Experimental: ketamine
    ketamine (1mg/kg)
    Interventions:
    • Drug: ketamine
    • Drug: ibuprofen or acetaminophen
  • Active Comparator: fentanyl
    fentanyl (1.5 micrograms/kg)
    Interventions:
    • Drug: fentanyl
    • Drug: ibuprofen or acetaminophen
Publications * Reynolds SL, Studnek JR, Bryant K, VanderHave K, Grossman E, Moore CG, Young J, Hogg M, Runyon MS. Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department. BMJ Open. 2016 Sep 8;6(9):e012190. doi: 10.1136/bmjopen-2016-012190.

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 11, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • single suspected, isolated extremity fracture that requires analgesia

Exclusion Criteria:

  • GCS < 15 at ED presentation,
  • reported allergy or adverse reaction to ketamine or fentanyl,
  • pregnancy,
  • intoxication,
  • hypotension (less than 70 mmHg +2x age or less than 90 mm Hg for patients greater than 11 years of age)
  • weight > 70 kg
  • patients receiving opioid analgesia administered prior to arrival
  • multiply injured patients (injuries to multiple extremities)
  • aberrant nasal anatomy that precludes IN medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 17 Years   (Child)
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 NCT02521415
Other Study ID Numbers  ICMJE INK-2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stacy Reynolds, Atrium Health
Study Sponsor  ICMJE Atrium Health
Collaborators  ICMJE
  • Carolinas Trauma Network Research Group
  • Charlotte, Houston, Milwaukee Prehospital Emergency Research Nodal Center-CHaMP-ERNC
Investigators  ICMJE
Principal Investigator: Stacy Reynolds, MD Carolinas Medical Center
PRS Account Atrium Health
Verification Date September 2016

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