Clinical trial NCT02519595: Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children
Official title: Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate, Deep Sedation
Keywords: Procedural sedation
ketamine
children
Lead sponsor: Children's Hospital of Michigan
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 182
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Children 3 -18 years of age
* Belonging to American Society of Anesthesiologists (ASA) classification 1 or 2
* Receiving IV ketamine for procedural sedation for orthopedic procedures,
* Incision and Drainage of skin abscess and laceration repair

Exclusion Criteria:

* Contraindications to use of Ketamine
* Parents or legal guardian not available or declined to provide informed consent
* Child declined to provide assent,
* Patients that received intramuscular ketamine,
* Patient that received benzodiazepines in addition to ketamine
* Children weighing \>100 kilogram
* Children with developmental disabilities.

Primary outcomes:
measure: Sedation Efficacy
timeFrame: Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours
measure: Pain
timeFrame: Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutes
Secondary outcomes:
measure: Sedation Duration
timeFrame: Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hours
measure: Additional Dose
timeFrame: Patients will be assessed during procedure . Approximately 1 hours
measure: Adverse Events
timeFrame: Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days.,
measure: Sedation Satisfaction
timeFrame: At the end of the procedure. Approximately 1 hour
Other outcomes:
Locations:
Study officials:
References: