Phase 4
Completed N=171
Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children
Moderate, Deep Sedation
Source: ClinicalTrials.gov NCT02519595 ↗
Enrolled (actual)
171
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Sedation Efficacy — 5.5; 6; 6 units on a scale — p=0.2
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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.
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. Informational only — not medical advice.