BACKGROUND AND OBJECTIVE: Sedation is commonly used to facilitate diagnostic procedures in children. The aim of our study was to investigate sedation in children usingpropofol alone or combined with fentanyl or midazolam with regard to efficacy, adverse reactions or side-effects related to the drugs, ease of operation for the endoscopist, and time to discharge from the post-anaesthesia care unit. METHODS: We prospectively studied 240 children, aged 1-12 yr of age, undergoing endoscopic procedures of the upper gastrointestinal tract. The patients were given an oral premedication with midazolam (0.5 mg kg(-1)) and were then randomly allocated to one of the three study groups: propofol alone (Group P), propofol with fentanyl 1 mug kg-1 (Group PF) or propofol with midazolam 0.1 mg kg(-1) (Group PM). Additional doses of propofol given during the procedure were recorded. Adequacy of sedation and ease of procedure (easy, adequate, impossible) were evaluated by the endoscopist, who was blinded as to the drugs used. RESULTS: The duration of the procedure and the recovery period were similar in the three groups. The number of patients requiring supplemental doses of propofol to permit safe completion of gastroscopy was 31 in Group P (=39%; eight of these required two additional doses), 14 in Group PM (=18%), and 11 in Group PF (=13%) (P < 0.05). There was a lower incidence of adverse events in Group PM and in Group PF than in Group P (P < 0.05). CONCLUSIONS:Propofol in combination with fentanyl or midazolam gives better sedation and ease of endoscopy than propofol alone.
RCT Entities:
BACKGROUND AND OBJECTIVE: Sedation is commonly used to facilitate diagnostic procedures in children. The aim of our study was to investigate sedation in children using propofol alone or combined with fentanyl or midazolam with regard to efficacy, adverse reactions or side-effects related to the drugs, ease of operation for the endoscopist, and time to discharge from the post-anaesthesia care unit. METHODS: We prospectively studied 240 children, aged 1-12 yr of age, undergoing endoscopic procedures of the upper gastrointestinal tract. The patients were given an oral premedication with midazolam (0.5 mg kg(-1)) and were then randomly allocated to one of the three study groups: propofol alone (Group P), propofol with fentanyl 1 mug kg-1 (Group PF) or propofol with midazolam 0.1 mg kg(-1) (Group PM). Additional doses of propofol given during the procedure were recorded. Adequacy of sedation and ease of procedure (easy, adequate, impossible) were evaluated by the endoscopist, who was blinded as to the drugs used. RESULTS: The duration of the procedure and the recovery period were similar in the three groups. The number of patients requiring supplemental doses of propofol to permit safe completion of gastroscopy was 31 in Group P (=39%; eight of these required two additional doses), 14 in Group PM (=18%), and 11 in Group PF (=13%) (P < 0.05). There was a lower incidence of adverse events in Group PM and in Group PF than in Group P (P < 0.05). CONCLUSIONS:Propofol in combination with fentanyl or midazolam gives better sedation and ease of endoscopy than propofol alone.