Phase 4 N=171 Randomized Quadruple-blind Treatment

Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children

Moderate, Deep Sedation

Bottom Line

View on ClinicalTrials.gov: NCT02519595 ↗

Enrolled (actual)

171

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcome: Primary: Sedation Efficacy — 5.5; 6; 6 units on a scale — p=0.2

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ketamine IV 1mg/kg (Drug); Ketamine IV 1.5mg/kg (Drug); Ketamine IV 2mg/kg (Drug)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: Children's Hospital of Michigan
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Sedation Efficacy	5.5; 6; 6	0.2
PRIMARY Pain	0; 0; 0	0.09
SECONDARY Sedation Duration	23; 24.5; 23	0.2
SECONDARY Additional Dose	8; 1; 2	—
SECONDARY Adverse Events	5; 5; 4; 4; 4; 6	0.8
SECONDARY Sedation Satisfaction	10; 2; 1; 12; 3; 6	0.011 sig

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02519595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.