PURPOSE: The purpose of this study was to compare the safety and efficacy of submucosal-administered meperidine (SM) and oral-administered meperidine (OM). Both regimens were used in conjunction with oral hydroxyzine for the sedation of children for dental treatment. METHODS:Twenty preschool-age children, with previous histories of uncooperative behavior, were randomly assigned to first receive a sedation regimen of either SM (0.5 mg/ lb), or OM (1 mg/lb), both with oral hydroxyzine (0.5 mg/lb). A cross-over design was utilized so that each child received both regimens. Safety was monitored through vital signs and side effects. Efficacy was measured with Houpt and Frankl behavior ratings. RESULTS: Vital signs remained stable during both treatments. Differences noted were clinically insignificant. The major side effects reported during submucosal injection included pain (58%) and edema (26%). All blinded behavior ratings, in both sedation regimens, significantly improved from presedation Frankl ratings. No significant differences existed between treatments. Success was 63% in the SM group and 80% in the OM group. The percentages were not statistically significant (P=.219). CONCLUSIONS: Both methods of administration were found to be safe and effective for sedating uncooperative pediatric dental patients. Neither was significantly more effective or safer than the other.
RCT Entities:
PURPOSE: The purpose of this study was to compare the safety and efficacy of submucosal-administered meperidine (SM) and oral-administered meperidine (OM). Both regimens were used in conjunction with oral hydroxyzine for the sedation of children for dental treatment. METHODS: Twenty preschool-age children, with previous histories of uncooperative behavior, were randomly assigned to first receive a sedation regimen of either SM (0.5 mg/ lb), or OM (1 mg/lb), both with oral hydroxyzine (0.5 mg/lb). A cross-over design was utilized so that each child received both regimens. Safety was monitored through vital signs and side effects. Efficacy was measured with Houpt and Frankl behavior ratings. RESULTS: Vital signs remained stable during both treatments. Differences noted were clinically insignificant. The major side effects reported during submucosal injection included pain (58%) and edema (26%). All blinded behavior ratings, in both sedation regimens, significantly improved from presedation Frankl ratings. No significant differences existed between treatments. Success was 63% in the SM group and 80% in the OM group. The percentages were not statistically significant (P=.219). CONCLUSIONS: Both methods of administration were found to be safe and effective for sedating uncooperative pediatric dental patients. Neither was significantly more effective or safer than the other.