OBJECTIVES: To determine whether post-operative administration of topical ropivacaine hydrochloride decreases morbidity following adenotonsillectomy. STUDY DESIGN: Prospective, randomized, double-blind clinical trial. SETTING: University referral center; ENT Department. PARTICIPANTS: Fourty one children, aged 4-16 years, undergoing tonsillectomy. METHODS: Patients received 1.0% ropivacaine hydrochloride soaked swabs packed in their tonsillar fossae while the control group received saline-soaked swabs. Mc Grath's face scale was used to compare the two groups in respect of pain control. Chi-square and two-tailed unpaired Student's t-tests or Mann-Whitney-U-tests were used to compare the two independent groups. As 10 we made 11 comparison between groups, for Bonferroni correction, p<0.005 was accepted as statistically significant. RESULTS: Only first hour there was no significant pain-relieving effect seen in the ropivacaine group (p>0.05). The other hours and days there were statistically significance between the two groups (p<0.001). Also, the other post-operative parameters such as nausea, fever, vomiting, odor, bleeding, otalgia and trismus were not statistically different between the two groups. There were no complications associated with ropivacaine hydrochloride. No patients in this study suffered systemic side effects related to the use of this medication. CONCLUSION: Locally 1.0% ropivacaine administration significantly relieves the pain of pediatric tonsillectomy and, it is a safe and effective method. High concentrations of ropivaciane may produce clinically significant pain relief. It is more effective to reduce of post-operative analgesic requirement after first hour.
RCT Entities:
OBJECTIVES: To determine whether post-operative administration of topical ropivacaine hydrochloride decreases morbidity following adenotonsillectomy. STUDY DESIGN: Prospective, randomized, double-blind clinical trial. SETTING: University referral center; ENT Department. PARTICIPANTS: Fourty one children, aged 4-16 years, undergoing tonsillectomy. METHODS:Patients received 1.0% ropivacaine hydrochloride soaked swabs packed in their tonsillar fossae while the control group received saline-soaked swabs. Mc Grath's face scale was used to compare the two groups in respect of pain control. Chi-square and two-tailed unpaired Student's t-tests or Mann-Whitney-U-tests were used to compare the two independent groups. As 10 we made 11 comparison between groups, for Bonferroni correction, p<0.005 was accepted as statistically significant. RESULTS: Only first hour there was no significant pain-relieving effect seen in the ropivacaine group (p>0.05). The other hours and days there were statistically significance between the two groups (p<0.001). Also, the other post-operative parameters such as nausea, fever, vomiting, odor, bleeding, otalgia and trismus were not statistically different between the two groups. There were no complications associated with ropivacaine hydrochloride. No patients in this study suffered systemic side effects related to the use of this medication. CONCLUSION: Locally 1.0% ropivacaine administration significantly relieves the pain of pediatric tonsillectomy and, it is a safe and effective method. High concentrations of ropivaciane may produce clinically significant pain relief. It is more effective to reduce of post-operative analgesic requirement after first hour.