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.


METHODS
Randomized double-blind controlled clinical trial.


METHODS
Tertiary care facility in Beirut, Lebanon.


METHODS
Ninety patients who underwent tonsillectomy allocated evenly in three groups.


METHODS
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.


METHODS
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).


CONCLUSIONS
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.
Naja
M Z
MZ
Anesthesia and Pain Medicine Department, Makassed General Hospital, P.O. Box 11-6301, Riad El-Solh, 11072210 Beirut, Lebanon. zouhnaja@yahoo.com
El-Rajab
M
M
Kabalan
W
W
Ziade
M F
MF
Al-Tannir
M A
MA
D000779:Anesthetics, Local / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007267:Injections; D008297:Male; D010149:Postoperative Pain / Q000209:etiology / Q000517:prevention & control*; D011300:Preoperative Care; D011446:Prospective Studies; D014068:Tonsillectomy / Q000009:adverse effects*
D000779:Anesthetics, Local