PURPOSE: A common concern of anesthesiologists is the management of children involved in stressful scenarios, and premedication is considered, in most situations, as useful to reduce the stress responses. This randomized placebo-controlled study was designed to evaluate two premedicants, ketamine versus a combination of fentanyl-droperidol, rectally administered, in pediatric surgical outpatients. METHODS: We randomly assigned 120 children to three equal groups to be rectally premedicated with ketamine 10 mg kg(-1) (group K), fentanyl 5 microg kg(-1) + droperidol 100 microg kg(-1) (group F), or saline 0.2 ml kg(-1) (group P). A blinded observer scored the children's behavior, according to a four-category behavioral scale, before premedication (time A), 45 min after premedication (time B), immediately before venipuncture (time C), and during the venipuncture (time D). Features of the premedication technique, complications, parents' opinions, and contraindications to hospital discharge were recorded. RESULTS: Patient discharge was delayed because of anesthesia side effects in 7 cases (5.8%) and surgical problems in 9 (7.5%). Group F showed a higher rate of postoperative nausea and vomiting (PONV) than group K, whereas the latter had a higher rate of behavioral disturbances. The data showed a significant difference in the behavioral score between groups F and P, groups K and P, and groups F and K at time B, and between groups K and P at time C. The reaction score at venipuncture shows a significant difference between groups K and P only. CONCLUSION: In this study, premedication with rectal ketamine showed significantly better overall results in the preoperative period than premedication with either fentanyl-droperidol or placebo.
RCT Entities:
PURPOSE: A common concern of anesthesiologists is the management of children involved in stressful scenarios, and premedication is considered, in most situations, as useful to reduce the stress responses. This randomized placebo-controlled study was designed to evaluate two premedicants, ketamine versus a combination of fentanyl-droperidol, rectally administered, in pediatric surgical outpatients. METHODS: We randomly assigned 120 children to three equal groups to be rectally premedicated with ketamine 10 mg kg(-1) (group K), fentanyl 5 microg kg(-1) + droperidol 100 microg kg(-1) (group F), or saline 0.2 ml kg(-1) (group P). A blinded observer scored the children's behavior, according to a four-category behavioral scale, before premedication (time A), 45 min after premedication (time B), immediately before venipuncture (time C), and during the venipuncture (time D). Features of the premedication technique, complications, parents' opinions, and contraindications to hospital discharge were recorded. RESULTS:Patient discharge was delayed because of anesthesia side effects in 7 cases (5.8%) and surgical problems in 9 (7.5%). Group F showed a higher rate of postoperative nausea and vomiting (PONV) than group K, whereas the latter had a higher rate of behavioral disturbances. The data showed a significant difference in the behavioral score between groups F and P, groups K and P, and groups F and K at time B, and between groups K and P at time C. The reaction score at venipuncture shows a significant difference between groups K and P only. CONCLUSION: In this study, premedication with rectal ketamine showed significantly better overall results in the preoperative period than premedication with either fentanyl-droperidol or placebo.