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<p>Procedural sedation and analgesia (PSA) are essential in pediatric emergency departments for performing painful or distressing interventions. This study aimed to compare the efficacy, safety, and recovery profiles of two commonly used sedation protocols: propofol/fentanyl and midazolam/fentanyl. In this randomized clinical trial, 84 children aged 3 months to 18 years requiring procedural sedation were assigned to receive either propofol/fentanyl or midazolam/fentanyl. Primary outcomes included procedural success and recovery time. Secondary outcomes were assessed using the Observational Scale of Behavioral Distress (OSBD), child- and caregiver-reported pain scores, and the Ramsay Sedation Scale (RSS). Adverse events were also monitored throughout. Both sedative combinations achieved 100% procedural success with no reported adverse events. Recovery time was significantly shorter with propofol/fentanyl compared to midazolam/fentanyl (median [IQR]: 14.50 [13.00–15.00] vs. 19.50 [17.25–21.00] minutes, <i>p</i> &lt; 0.001), and this effect remained robust after adjusting for covariates using a Generalized Linear Model with Gamma distribution and log link (Exp(B) = 0.67, 95% CI: 0.63–0.71, <i>p</i> &lt; 0.001). No significant differences were observed in procedural distress (OSBD score: 1.00 [1.00–2.00] vs. 1.50 [1.00–2.50], <i>p</i> = 0.74), child-reported pain (4.00 [3.00–4.00] vs. 3.50 [2.00–4.00], <i>p</i> = 0.18), caregiver-reported pain (4.00 [2.00–4.00] vs. 3.00 [2.00–4.00], <i>p</i> = 0.45), or sedation depth (<i>p</i> = 0.49). Both regimens were safe and effective for pediatric procedural sedation. Propofol/fentanyl was associated with a significantly shorter recovery time, an association that persisted after adjusting for age, sex, and procedure pain severity, suggesting a potential recovery-time advantage in similar clinical settings. Sedative selection should still be individualized based on procedure type, patient factors, and institutional capabilities. Name of the registry: Comparison of safety and efficacy of propofol/fentanyl and midazolam/fentanyl for procedural sedation, Trial registration number: IRCT20250525065887N1, Registration date: 2025-05-28, URL of trial registry record: <a href="https://irct.behdasht.gov.ir/trial/83788">https://irct.behdasht.gov.ir/trial/83788</a>.</p>

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Comparison of propofol/fentanyl and midazolam/fentanyl for pediatric procedural sedation in the emergency department: a randomized clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月5日

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  • Nastaran Sadat Mahdavi,
  • Hojjat Derakhshanfar,
  • Alireza Fahimzad,
  • Vahide Zeinali,
  • Korosh Soltaniyeh Zanjani

摘要

Procedural sedation and analgesia (PSA) are essential in pediatric emergency departments for performing painful or distressing interventions. This study aimed to compare the efficacy, safety, and recovery profiles of two commonly used sedation protocols: propofol/fentanyl and midazolam/fentanyl. In this randomized clinical trial, 84 children aged 3 months to 18 years requiring procedural sedation were assigned to receive either propofol/fentanyl or midazolam/fentanyl. Primary outcomes included procedural success and recovery time. Secondary outcomes were assessed using the Observational Scale of Behavioral Distress (OSBD), child- and caregiver-reported pain scores, and the Ramsay Sedation Scale (RSS). Adverse events were also monitored throughout. Both sedative combinations achieved 100% procedural success with no reported adverse events. Recovery time was significantly shorter with propofol/fentanyl compared to midazolam/fentanyl (median [IQR]: 14.50 [13.00–15.00] vs. 19.50 [17.25–21.00] minutes, p < 0.001), and this effect remained robust after adjusting for covariates using a Generalized Linear Model with Gamma distribution and log link (Exp(B) = 0.67, 95% CI: 0.63–0.71, p < 0.001). No significant differences were observed in procedural distress (OSBD score: 1.00 [1.00–2.00] vs. 1.50 [1.00–2.50], p = 0.74), child-reported pain (4.00 [3.00–4.00] vs. 3.50 [2.00–4.00], p = 0.18), caregiver-reported pain (4.00 [2.00–4.00] vs. 3.00 [2.00–4.00], p = 0.45), or sedation depth (p = 0.49). Both regimens were safe and effective for pediatric procedural sedation. Propofol/fentanyl was associated with a significantly shorter recovery time, an association that persisted after adjusting for age, sex, and procedure pain severity, suggesting a potential recovery-time advantage in similar clinical settings. Sedative selection should still be individualized based on procedure type, patient factors, and institutional capabilities. Name of the registry: Comparison of safety and efficacy of propofol/fentanyl and midazolam/fentanyl for procedural sedation, Trial registration number: IRCT20250525065887N1, Registration date: 2025-05-28, URL of trial registry record: https://irct.behdasht.gov.ir/trial/83788.