Effect of Bupivacaine-infused Fibrin Sealant Application on Post-tonsillectomy Pain & Hemorrhage
Status:
Terminated
Trial end date:
2017-05-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the effect of combining two interventions already in
use at some institutions for reducing post-operative pain following tonsillectomy or
adenotonsillectomy. The standard of care at most institutions is to leave the tonsillectomy
wound bed exposed to heal on its own over one to two weeks. At many institutions, surgeons
inject or topically apply local anesthetics such as bupivacaine hydrochloride to the
tonsillectomy wound bed to help reduce post-operative pain. At other institutions, surgeons
apply a layer of fibrin sealant, which is derived from the proteins that help form blood
clots in blood, to the tonsillectomy wound bed in order to cover the site and reduce
irritation and exposure of the wound bed. Use of fibrin sealant has the additional benefit of
potentially reducing postoperative bleeding (hemorrhage) rates. Both the post-tonsillectomy
use of bupivacaine (injection and topical) and the use of topical fibrin sealant application
have been studied previously in the scientific literature; some studies show a clear benefit,
others show no significant reduction in pain when they are used. No studies have documented
harm. The purpose of this study is to evaluate the efficacy of infusing bupivacaine
anesthetic into the fibrin sealant prior to application to the tonsillectomy wound bed. In
this way, the combined product would function as a sort of "medicated bandaid" covering the
painful wound bed and slowly delivering an entirely safe total dose of bupivacaine into the
wound bed to reduce post-operative pain. Parents will be provided post-operative pain
measurements to complete during the first 10 postoperative days and return to the researchers
for data analysis.