Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children
Condition: Bone Fractures
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the effectiveness of intranasal (IN) ketamine compared to standard
      intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the
      paediatric population. The aim is to assess if IN administration is equivalent to the current
      standard of care, IV. The population to be studied is children 5-17 years of age who require
      a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty
      in masking interventions, each participant will recieve both IV and IN interventions, only
      one of which will be the real drug. Procedural conscious sedation (PCS) will be assessed
      using the University of Michigan Sedation Scale (UMSS).
    

Detailed description: 
      Randomization and concealment of allocation will be pharmacy-controlled using a
      computer-based random number generator. The treating physician, research assistant, and
      participant will be blinded to the intervention. Eligible participants will be randomized in
      a 1:1 allocation ratio with a stratified block design of six to either (1) IN ketamine (each
      single dose, 8 mg/kg prepared in 0.9% NS in 3 mL syringe and atomizer, to a maximum of 1.5
      mL) PLUS IV 0.9% NS 0.02 mL/kg or (2) IV ketamine (single dose, 1 mg/kg, to a maximum 100 mg)
      PLUS intranasal 0.9% NS 0.08 mL/kg divided to both nares. Due to the perceptible differences
      in interventional routes, each participant will receive both IV and IN interventions using
      this double-dummy approach. For IN dose volumes less than or equal to 0.5 mL, the entire dose
      will be delivered into 1 nostril and for doses greater than 0.5 mL, the dose will be divided
      equally between both nares. Adjuctive sedation will be given as needed in the form of IV
      ketamine, 1 mg/kg every 10 minutes for participants who do not achieve adequate sedation at
      20 minutes (UMSS score of 4). A figure of the atomizer device used to deliver the IN agent
      has been uploaded. Eligible participants (defined in section 2.5 above) will be identified by
      the treating physician after viewing the radiographs and performing a clinical assessment.
      The physician will then inform a research assistant (RA) that the participant is eligible.
      The RA will then seek informed consent and explain the protocol to the family. Baseline
      demographic information will be obtained. Informed consent for PCS and a pre-anesthetic
      assessment will be performed by the treating physician in accordance with the usual standard
      of care. UMSS scores will be obtained by a trained RA at 5 minutes pre-intervention,
      intervention (0 minutes) and every 5 minutes thereafter for 60 minutes post-intervention or
      until the participant is ambulatory and drinking well, whichever is longer. Participants will
      receive standard monitoring of oxygen saturation, blood pressure, respiratory rate, apnea,
      heart rate, and rash by the attending nurse and physician every 5 minutes as per the usual
      standard of care. The usual standard of care also includes monitoring post-anesthetic for the
      presence of known idiosyncratic effects of ketamine that include vomiting, seizure, headache,
      emergence reaction, and hypersensitivity. The RA will obtain this information from the
      nursing record at discharge. Immediately prior to discharge, the RA will also record the
      duration of stay in the ED and parental satisfaction with PCS. 1. Chiaretti et al. 2011.
      Intranasal lidocaine and midazolam for procedural sedation in children. Arch Dis Child.
      96;160-163
    

Intervention name(s): Ketamine and saline
Intervention type(s): Drug
Intervention description(s): Ketamine intravenous and intranasal
Other intervention name(s): Ketamine hydrochloride
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment