Intravenous ketamine for children's procedural sedation: serious events were rare in 58,752 children

Design

Systematic review and pooled analysis of 20 studies, each with 250 or more children

Population

58,752 children given intravenous ketamine for procedural sedation in emergency departments

Primary outcome

Frequency of sentinel and serious adverse events, and their predictors

Effect

Sentinel events 0.0041% (95% CI 0.0010% to 0.016%); serious adverse events 0.33%

This systematic review pooled 20 studies with at least 250 children each, totalling 58,752 children who received intravenous ketamine for procedural sedation in emergency departments, and published in May. It looked at the frequency of adverse events and their predictors.

No deaths or permanent adverse outcomes were reported. Sentinel events (tracheal intubation, neuromuscular blockade, chest compressions, aspiration or vasoactive drugs) had a pooled frequency of 0.0041% (95% CI 0.0010% to 0.016%), about 1 per 24,390 sedations. Serious adverse events, defined more broadly, were reported in 0.33%. Three modest predictors were age 10 or over, an upper respiratory infection and co-administered opioids, each adding about one serious event per 106, 114 and 161 sedations. American Society of Anesthesiologists status and co-administered benzodiazepines were not predictors.

The studies were observational and varied in how they defined events, so the numbers are estimates. The authors conclude that the evidence strongly supports the safety of emergency department ketamine sedation in children. Equipment, monitoring and trained staff remain essential, and these findings apply to the intravenous route only.

• Serious events were rare in this review, which supports intravenous ketamine where monitoring and airway skills are available.
• Serious adverse events were 0.33%; sentinel events about 1 in 24,390.
• Take extra care in children aged 10 or over, with an upper respiratory infection or given opioids too.
• These data are for the intravenous route; do not extend them to other routes or settings without monitoring.

Why it matters

It gives a denominator for a drug that many departments use daily, and shows where the small excess risks sit.

Don't overread it

The studies were observational, and the review does not cover other routes, other drugs or settings without monitoring.

The statistics, in plain English

A pooled rate of 0.0041% sounds negligible because the events are so rare; even the upper end of the interval is 0.016%, about 1 in 6,000. The broader serious-event rate of 0.33% is the more useful figure for planning.

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