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Evaluation of the safety of using propofol for paediatric procedural sedation: A systematic review and meta-analysis
Sunhee Kim1, Seokyung Hahn2,3, Myoung-Jin Jang4
1Interdisciplinary Program in Medical Informatics, Seoul National University College of Medicine, Seoul, 03080, Korea.
Insights
Propofol offers faster recovery for pediatric procedural sedation without significant cardiac or respiratory risks compared to other agents. This systematic review supports its positive consideration for regulatory and reimbursement decisions.
Area of Science:
- Anesthesiology
- Pediatric Sedation
- Evidence-Based Medicine
Background:
- Propofol is a common choice for pediatric procedural sedation.
- Concerns exist regarding potential respiratory and cardiac complications.
- Off-label use is prevalent in many countries despite available trials.
Purpose of the Study:
- To systematically review and meta-analyze randomized controlled trials (RCTs) comparing propofol with other agents for pediatric procedural sedation.
- To provide evidence for regulatory and reimbursement policy considerations.
- To assess the safety and efficacy of propofol in pediatric patients.
Main Methods:
- Systematic literature search of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials up to January 31, 2018.
- Meta-analysis of 30 identified RCTs.
- Comparison of propofol with alternative sedative agents or opioids.
Main Results:
- Propofol sedation demonstrated advantages in recovery time compared to other drugs.
- No excessive cardiovascular or respiratory adverse events were noted with propofol.
- Safety profiles for coughing, nausea, vomiting, and emergence delirium were similar to other agents.
Conclusions:
- The evidence supports propofol as a favorable option for pediatric procedural sedation.
- Regulatory bodies and policymakers should consider propofol more positively.
- Further evaluation may inform reimbursement policies for propofol in pediatric care.
Abstract:
Propofol is one of the most widely used drugs for paediatric procedural sedation owing to its known advantages, but some concerns remain regarding respiratory and/or cardiac complications in patients receiving propofol. Although a considerable number of randomised controlled clinical trials (RCTs) have been conducted to compare it with other sedative agents or opioids for children undergoing various procedures, propofol is still being used off-label for this indication in many countries. We performed a systematic review and meta-analysis of those RCTs to provide an overall summation of evidence that can potentially be considered for further regulatory decisions, including reimbursement policies. We searched for RCTs in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from their inception to January 31, 2018. Our meta-analysis of 30 RCTs confirmed that propofol sedation had advantages in recovery time when compared with other drugs, without excessive concerns for cardiovascular or respiratory adverse events. Its safety profile regarding coughing, nausea or vomiting, and emergence delirium was also similar to that of other drugs. The overall evidence suggests that propofol sedation for paediatric procedures should be considered more positively in the context of regulatory decisions.
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