BACKGROUND AND OBJECTIVE: Although midazolam is commonly given orally to infants and small children for premedication, the taste is sometimes unacceptable even when mixed with syrup. We tested the efficacy and safety of oral fentanyl compared with oral midazolam in a randomized open-label study. METHODS:Fifty-one children, aged 12-107 months and weighing 10-25 kg, were randomly assigned to fentanyl or midazolam treatment groups. Midazolam (5 mg) or fentanyl (0.1 mg) was given orally from a small bottle with a small orifice 30 min before transfer to the preoperative holding room. The excitation-sedation conditions of the patients were assessed before and after general anaesthesia. RESULTS: The preoperative scores did not differ significantly between the two groups. No major complications were observed in either group. Postoperative vomiting occurred in 5 of 27 (18.5%) patients treated with oral fentanyl and in none of 24 of those treated with midazolam. CONCLUSIONS: Oral administration of fentanyl 30 min before entrance to the holding room for an operation from a bottle with a small orifice is a premedication option for children between 1 and 8 yr of age.
RCT Entities:
BACKGROUND AND OBJECTIVE: Although midazolam is commonly given orally to infants and small children for premedication, the taste is sometimes unacceptable even when mixed with syrup. We tested the efficacy and safety of oral fentanyl compared with oral midazolam in a randomized open-label study. METHODS: Fifty-one children, aged 12-107 months and weighing 10-25 kg, were randomly assigned to fentanyl or midazolam treatment groups. Midazolam (5 mg) or fentanyl (0.1 mg) was given orally from a small bottle with a small orifice 30 min before transfer to the preoperative holding room. The excitation-sedation conditions of the patients were assessed before and after general anaesthesia. RESULTS: The preoperative scores did not differ significantly between the two groups. No major complications were observed in either group. Postoperative vomiting occurred in 5 of 27 (18.5%) patients treated with oral fentanyl and in none of 24 of those treated with midazolam. CONCLUSIONS: Oral administration of fentanyl 30 min before entrance to the holding room for an operation from a bottle with a small orifice is a premedication option for children between 1 and 8 yr of age.
Authors: Ravil R Petrov; Yeon Sun Lee; Ruben S Vardanyan; Lu Liu; Shou-wu Ma; Peg Davis; Josephine Lai; Frank Porreca; Todd W Vanderah; Victor J Hruby Journal: Bioorg Med Chem Lett Date: 2013-04-03 Impact factor: 2.823