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Int. J. Pediatr. Otorhinolaryngol. · Oct 2005
Randomized Controlled TrialPre-incisional infiltration for pediatric tonsillectomy: a randomized double-blind clinical trial.
- M Z Naja, M El-Rajab, W Kabalan, M F Ziade, and M A Al-Tannir.
- Anesthesia and Pain Medicine Department, Makassed General Hospital, P.O. Box 11-6301, Riad El-Solh, 11072210 Beirut, Lebanon. zouhnaja@yahoo.com
- Int. J. Pediatr. Otorhinolaryngol. 2005 Oct 1;69(10):1333-41.
ObjectiveTonsillectomy is frequently associated with post-operative pain of considerable duration. The aim of the current study is to corroborate our previous observational data by conducting a prospective double-blind placebo-controlled randomized clinical trial to determine the potential effect of pre-incision infiltration of local anesthesia on post-operative pain after tonsillectomy.DesignRandomized double-blind controlled clinical trial.SettingTertiary care facility in Beirut, Lebanon.PatientsNinety patients who underwent tonsillectomy allocated evenly in three groups.InterventionsPre-incision infiltration of 1.5 local anesthetic mixture in each tonsil was performed in conjunction with general anesthesia (infiltration, n=30). Pre-incision infiltration of 1.5 ml of 0.9% of normal saline was applied with general anesthesia (placebo, n=30). GA received only general anesthesia.Outcome MeasuresPost-operative pain at rest, eating soft diet, jaw opening at 0, 6, 12, and once daily for the 10-day follow-up period, hemodynamic stability, hospital stay, parent and surgeon satisfaction, ear pain and analgesics consumption were assessed.ResultsHemodynamic stability was maintained during pre, per and post-operation. 93.1% of infiltration group left the hospital the same day compared to 60% in placebo groups and 41.4% in general anesthesia group (p=0.001). Surgeon's satisfaction was significantly higher in infiltration group compared to placebo and general anesthesia groups (p=0.001). Parent's satisfaction was significantly higher in infiltration group (89.65%) compared to general anesthesia group (13.8%) and placebo group (36.7%) (p=0.001). The average pain scores at rest, on jaw opening and when eating soft diet were significantly lower in infiltration group compared to placebo group and general anesthesia group (p<0.05). Analgesic consumption in placebo and general anesthesia groups were significantly higher compared to infiltration group (p<0.05).ConclusionThis modified pre-incision infiltration of anesthetic mixture combined with general anesthesia reduces significantly post-tonsillectomy pain in children and provides a more rapid return to normal activity compared to general anesthesia alone or in combination with a placebo infiltration.
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