Indian journal of pediatrics · 2026
Ketamine-Fentanyl Versus Ketamine-Midazolam for Sedation in Children Undergoing Flexible Fiber-optic Bronchoscopy - An Open-label Randomized Controlled Trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Ramesh Gopika, Ramakrishna Golla, Kumar Ketan, Chokhani Aarushi, Das Rashmi Ranjan, Behera Sasmita, Misra Satyajeet, Gulla Krishna Mohan
Аннотация
OBJECTIVES: To compare the number of severe cough episodes during flexible fiberoptic bronchoscopy (FOB) in children receiving intravenous (IV) ketamine and fentanyl (KF) to those receiving IV ketamine and midazolam (KM).
METHODS: A parallel-group, open-label, randomized controlled trial was conducted at a tertiary care center. Children aged 6 mo to 15 y undergoing FOB were enrolled, excluding those with anticipated difficult airway, significant respiratory compromise, hemodynamic instability, and those undergoing interventional procedures. Video recordings of the entire procedure were reviewed by a blinded observer to assess the primary outcome.
RESULTS: Seventy-five participants were enrolled; 38 in the KM group and 37 in the KF group. The KF group had a lower median number of severe cough episodes [1 (0-4) vs. 3 (1-6), P = 0.054], though not statistically significant. No significant differences were found in time to reach Ramsay Sedation Scale (RSS) 4, bronchoscopy scores, need for additional sedation, or adverse events. No participants developed bradycardia, hypotension, apnea, laryngospasm, or deep desaturation. Post-hoc analysis showed a lower frequency of severe cough episodes (per minute procedure time) in the KF group [0.1 (0-0.4) vs. 0.35 (0.1-0.6), P = 0.008].
CONCLUSIONS: This RCT did not demonstrate a significant difference in severe cough episodes with the ketamine-fentanyl combination compared to ketamine-midazolam in children undergoing FOB. However, the post-hoc analysis does indicate some benefit with the use of ketamine-fentanyl. There was no increase in adverse events with the combination.
METHODS: A parallel-group, open-label, randomized controlled trial was conducted at a tertiary care center. Children aged 6 mo to 15 y undergoing FOB were enrolled, excluding those with anticipated difficult airway, significant respiratory compromise, hemodynamic instability, and those undergoing interventional procedures. Video recordings of the entire procedure were reviewed by a blinded observer to assess the primary outcome.
RESULTS: Seventy-five participants were enrolled; 38 in the KM group and 37 in the KF group. The KF group had a lower median number of severe cough episodes [1 (0-4) vs. 3 (1-6), P = 0.054], though not statistically significant. No significant differences were found in time to reach Ramsay Sedation Scale (RSS) 4, bronchoscopy scores, need for additional sedation, or adverse events. No participants developed bradycardia, hypotension, apnea, laryngospasm, or deep desaturation. Post-hoc analysis showed a lower frequency of severe cough episodes (per minute procedure time) in the KF group [0.1 (0-0.4) vs. 0.35 (0.1-0.6), P = 0.008].
CONCLUSIONS: This RCT did not demonstrate a significant difference in severe cough episodes with the ketamine-fentanyl combination compared to ketamine-midazolam in children undergoing FOB. However, the post-hoc analysis does indicate some benefit with the use of ketamine-fentanyl. There was no increase in adverse events with the combination.