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A comparison of sedation with midazolam-ketamine versus propofol-fentanyl during endoscopy in children: a randomized trial.

ABSTRACT: We aimed to compare the efficacy and safety of midazolam plus ketamine versus fentanyl plus propofol combination administered to children undergoing upper gastrointestinal endoscopy (UGE) and to determine the most appropriate sedation protocol.This prospective, randomized, single-blind study included patients between the ages of 4 and 17 years who underwent UGE for diagnostic purposes. Patients were divided randomly into groups A (midazolam-ketamine combination, n=119) and B (fentanyl plus propofol combination, n=119). The effectiveness of the sedation and complications during the procedure and recovery period were recorded.The processes started without an additional dose of the drug for 118 patients (99.1%) in group A and for 101 patients (84.8%) in group B (P=0.001). The average dose of ketamine administered to the patients in group A was 1.03±0.15?mg/kg and the average dose of propofol administered to the patients in group B was 1.46±0.55?mg/kg. None of the patients stopped the endoscopic procedure in group A, but one patient (0.8%) had to discontinue the endoscopic procedure in group B. 27 patients in group A (22.7%) and 41 patients (34.5%) in group B developed complications during the procedure (P=0.044). The rate of complications during the recovery of group A (110 patients, 92.4%) was significantly higher than that in group B (48 patients, 40.3%) (P=0.001).In children, UGE procedures can be quite comfortable when using the midazolam-ketamine combination. However, adverse effects related to ketamine were observed during recovery.

SUBMITTER: Akbulut UE

PROVIDER: S-EPMC5134819 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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A comparison of sedation with midazolam-ketamine versus propofol-fentanyl during endoscopy in children: a randomized trial.

Akbulut Ulas E UE Saylan Sedat S Sengu Bilal B Akcali Gulgun E GE Erturk Engin E Cakir Murat M

European journal of gastroenterology & hepatology 20170101 1

<h4>Purpose</h4>We aimed to compare the efficacy and safety of midazolam plus ketamine versus fentanyl plus propofol combination administered to children undergoing upper gastrointestinal endoscopy (UGE) and to determine the most appropriate sedation protocol.<h4>Materials and methods</h4>This prospective, randomized, single-blind study included patients between the ages of 4 and 17 years who underwent UGE for diagnostic purposes. Patients were divided randomly into groups A (midazolam-ketamine ...[more]

PMID: 27676093

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Project description:Dexmedetomidine as a sole agent showed limited use for painful procedures due to its insufficient sedative/analgesic effect, pronounced hemodynamic instability and prolonged recovery. The aim of this study was to compare the effects of dexmedetomidine-ketamine (DK) versus dexmedetomidine-midazolam-fentanyl (DMF) combination on the quality of sedation/analgesia and recovery profiles for monitored anesthesia care (MAC).Fifty six patients undergoing chemoport insertion were randomly assigned to group DK or DMF. All patients received 1 μg.kg(-1) dexmedetomidine over 10 min followed by 0.2-1.0 μg.kg(-1)h(-1) in order to maintain 3 or 4 of modified Observer's Assessment of Analgesia and Sedation score checked every 3 min. At the start of dexmedetomidine infusion, patients in group DK or DMF received 0.5 mg.kg(-1) ketamine or 0.05 mg.kg(-1) midazolam + 0.5 μg.kg(-1) fentanyl intravenously, respectively. When required, rescue sedatives (0.5 mg.kg-1 of ketamine or 0.05 mg.kg-1 of midazolam) and analgesics (0.5 mg.kg-1 of ketamine or 0.5 μg.kg-1 of fentanyl) were given to the patients in DK or DMF group, respectively. The primary outcome of this study was the recovery parameters (time to spontaneous eye opening and the length of the recovery room stay). The secondary outcomes were parameters indicating quality of sedation/analgesia, cardiorespiratory variables, and satisfaction scores.There were no significant differences in the onset time, time to spontaneous eye opening, recovery room stay, the incidences of inadequate analgesia, hypotension and bradycardia between the two groups. Despite lower infusion rate of dexmedetomidine, more patients in the DMF group had bispectral index (BIS) < 60 than in the DK group and vice versa for need of rescue sedatives. The satisfaction scores of patients, surgeon, and anesthesiologist in the DMF group were significantly better than the DK group.The DK and DMF groups showed comparable recovery time, onset time, cardiorespiratory variables, and analgesia. However, the DMF group showed a better sedation quality and satisfaction scores despite the lower infusion rate of dexmedetomidine, and a higher incidence of BIS < 60 than the DK group.Clinical Trial Registry of Korea KCT0000951 , registered 12/12/2013.

Dataset Information

A comparison of sedation with midazolam-ketamine versus propofol-fentanyl during endoscopy in children: a randomized trial.

Publications

A comparison of sedation with midazolam-ketamine versus propofol-fentanyl during endoscopy in children: a randomized trial.

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