IN Sub-Dissociative Ketamine vs IN Fentanyl
Condition: Bone Fracture
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): ketamine; fentanyl; ibuprofen or acetaminophen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intranasal (IN) sub-dissociative ketamine (1mg/kg); Intranasal (IN) fentanyl (1.5 micrograms/kg); 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention
Other intervention name(s): intranasal pain medication; intranasal pain medication
Intervention MeSH terms: Acetaminophen; Ibuprofen; Fentanyl; Ketamine; Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment