Written by Shannon Markus
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This systematic review suggests that non-injectable ketamine (oral or intranasal) can provide effective and safe pediatric procedural sedation, particularly compared with other oral agents, although the certainty of evidence is low.
Sedation without the stick
This systematic review assessed noninjectable ketamine (oral and intranasal) for pediatric procedural sedation in the emergency department. Using PRISMA methodology and a comprehensive multi-database search through July 2025, 12 studies (7 RCTs, 5 observational; n=1,484) were included. Oral ketamine at 5–10 mg/kg, particularly when combined with midazolam, generally achieved adequate sedation with onset of 15–35 minutes and duration of 60–265 minutes, while intranasal ketamine demonstrated faster onset (~10 minutes). Duration for IN ketamine was 238 minutes, but this was only derived from a single study. Sedation success exceeded 80% in several cohort studies, and higher oral doses or combination regimens were associated with reduced need for additional “rescue” sedation. No study reported serious cardiopulmonary adverse events requiring invasive airway intervention; minor adverse effects were uncommon and comparable to oral midazolam. The study was strengthened by rigorous methodology and structured bias assessment; limitations include substantial heterogeneity in dosing, routes, procedures, and outcome definitions, with overall low certainty of evidence for many efficacy outcomes.
How does this change my practice?
This review doesn’t change my preference for IV ketamine, given its speed and predictability. That said, I’m more open to flexibility in select cases based on the safety and comfort benefits highlighted here. Oral or intranasal ketamine seem like a reasonable way to spare kids the trauma of an IV stick, but my eyes popped a little when I saw the upper range of sedation duration with oral ketamine (265 minutes?!?). Importantly, most studies compared PO/IN ketamine to other ORAL agents—not IV ketamine. While Non-IV ketamine looks favorable relative to other oral sedatives, the time tradeoff between IV and non-IV ketamine is really hard to justify in a busy ED.
Source
Non-Injectable Ketamine for Pediatric Sedation in the Emergency Department: A Systematic Review. Acad Emerg Med. 2025 Dec;32(12):1344-1355. doi: 10.1111/acem.70163. Epub 2025 Oct 10. PMID: 41069251.
View JournalFeed Critical Appraisal
Critical Appraisal
Study Identification
Background
Study Question
Study Design & Conduct
Prospective / Retrospective: Not applicable
Multicenter: Not applicable
Unit of Allocation: Not applicable
Unit of Analysis: Studies
Randomization Method: Not applicable
Allocation Concealment: Not applicable
Blinding: Not applicable
Follow-up Duration: Not applicable
Population
- Pediatric patients (<18 years)
- Procedural sedation with noninjectable ketamine
- Emergency department setting
- Case reports
- Review articles
- Nonrandomized and/or pilot clinical trials
- Studies reported in abstract form
- Non-English studies
Number Enrolled: 1484
Number Analyzed: 1484
Key Baseline Characteristics
Sex: Not reported
Disease Severity: Not reported
Care Setting Distribution: Emergency Department
Exposures / Interventions
Description: Noninjectable ketamine for procedural sedation
Definition / Dose: Oral ketamine (5-10 mg/kg)
Timing: During procedural sedation
Classification Method: Not reported
Protocolized / Discretionary: Not reported
Description: Oral midazolam and other oral comparators
Definition: Not applicable
Outcomes & Results
Primary Outcomes
Definition: Effective sedation with noninjectable ketamine
Time Point: During procedural sedation
Measurement Method: Sedation scales
Results: Oral ketamine provided effective sedation
Secondary Outcomes
Definition: Time to achieve sedation
Time Point: 15-35 minutes
Measurement Method: Not reported
Results: 15-35 minutes
Definition: Duration of sedation effect
Time Point: 60-265 minutes
Measurement Method: Not reported
Results: 60-265 minutes
Definition: Incidence of adverse events
Time Point: During and after sedation
Measurement Method: Not reported
Results: No serious adverse events reported
Definition: Requirement for additional sedation
Time Point: During procedural sedation
Measurement Method: Not reported
Results: Lower need with oral ketamine
Risk of Bias
Risk of Bias - AMSTAR 2
- Protocol Registered (Low): The study was registered in PROSPERO.
- Comprehensive Search Strategy (Low): Multiple databases were searched with a defined strategy.
- Study Selection in Duplicate (Low): Study selection was performed by two independent reviewers.
- Data Extraction in Duplicate (Low): Data extraction was performed by two independent reviewers.
- Risk of Bias Assessed (Low): Risk of bias was assessed using Cochrane and NOS tools.
- Risk of Bias Used in Interpretation (Low): Risk of bias was considered in the interpretation of results.
- Meta-analysis Methods Appropriate (Not applicable): Meta-analysis was not conducted due to heterogeneity.
- Publication Bias Assessed (Low): Publication bias was considered less important due to fewer studies per outcome.
- Funding of Included Studies Reported (Low): Funding was disclosed for the systematic review.
- List of Excluded Studies Provided (Low): Reasons for exclusion were documented.
- Heterogeneity Assessed (Low): Heterogeneity was acknowledged and discussed.
- Conflicts of Interest Reported (Low): Conflicts of interest were declared.
- Other Critical Flaws Reported (Low): No critical flaws were identified.
Transparency
COI Statement Present: TRUE
