Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children
Condition: Moderate, Deep Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      There is a wide variation of published IV ketamine dosing regimens used for procedural
      sedation in children in the Emergency Department (ED). The purpose of the study was to
      compare the efficacy, duration of sedation and adverse events between the three commonly
      administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg and 2 mg/kg) using the traditional
      administration method of 30-60 second infusion for ED sedation in children.
    

Detailed description: 
      This was a prospective, double-blind, randomized controlled trial of children aged 3 to 18
      years who received IV ketamine for procedural sedation and analgesia (PSA) for orthopedic
      procedures, incision and drainage (I & D) of skin abscess and laceration repair in an inner
      city, tertiary care pediatric ED. Random sequence allocation was performed using a
      computer-generated, random number table by the study research pharmacist. The study
      participants were grouped according to their age as follows (1) 3-6 years (2) 7-12 years (3)
      13-18 years. Children from each age group were assigned in equal numbers to all three
      ketamine dosing (1 mg/kg, 1.5 mg/kg and 2 mg/kg) groups using random permuted blocks
      stratified by the pharmacist. All ED staff including the physician and the nurse in charge of
      sedation, the study research assistant, the parents/guardians and the study subjects were
      blinded to the randomization and the group assignments. The dosage and administration of
      additional doses of ketamine were left to the discretion of the ED physician in charge of the
      sedation. The research team did not participate in the clinical care including sedation of
      the patient. Children were monitored per ED policy for the entire duration of sedation. Three
      1 ml blood samples for the ketamine assay was collected from the existing intravenous access
      at three time intervals: 3-5 minutes after ketamine administration, at midpoint during the
      procedure and prior to discharge of the patient from the ED. In the event a second dose of
      ketamine was administered, a 4th 1 ml sample was collected 3-5 minutes after the 2nd dose in
      children weighing >20 kilograms. Patient demographics, procedure type, NPO status , ASA
      classification, pain medication administered prior to sedation (timing, dosage and type),
      number and total doses of ketamine administered after the initial study dose, sedation
      efficacy and duration, length of procedure, adverse events related to sedation, interventions
      performed to address the adverse events and patient disposition were collected. The study
      research assistant also performed a follow up phone call to the parents/caregivers of the
      children 48 hours after ED discharge to collect information on adverse events that happened
      at home . A total of 3 attempts were made to contact the parent/caregiver after which the
      participant was considered as lost to followup.
    

Intervention name(s): Ketamine IV 1mg/kg; Ketamine IV 1.5mg/kg; Ketamine IV 2mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intervention: Ketamine IV 1mg/kg; Intervention: Ketamine IV 1.5 mg/kg; Intervention: Ketamine IV 2 mg/kg
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Procedural sedation; ketamine; children