Trial reportIndian journal of pediatrics2026
Ketamine-Fentanyl Versus Ketamine-Midazolam for Sedation in Children Undergoing Flexible Fiber-optic Bronchoscopy - An Open-label Randomized Controlled Trial.
Trial report in Indian journal of pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
8 authors.
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Abstract
objectivesTo 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).
methodsA 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.
resultsSeventy-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].
conclusionsThis 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.
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