Pre-incisional infiltration for pediatric tonsillectomy: a randomized double-blind clinical trial.

OBJECTIVE: Tonsillectomy 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.

DESIGN: Randomized double-blind controlled clinical trial.

SETTING: Tertiary care facility in Beirut, Lebanon.

PATIENTS: Ninety patients who underwent tonsillectomy allocated evenly in three groups.

INTERVENTIONS: Pre-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 MEASURES: Post-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.

RESULTS: Hemodynamic 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).

CONCLUSION: This 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.