The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
Cleft Palate is a condition which affects up to 1 in 500 live births. Current treatment is
surgery to correct the underlying anomaly. Children born with cleft palate typically undergo
surgery at age 12 months. Standard ways to stop surgical bleeding include direct pressure and
the use of electrocautery (burning of the tissue). Other products are available to help
lessen blood loss. One of these includes a fibrin sealant. Fibrin is the key component of a
blood clot. When a fibrin sealant is applied there are a variety of potential benefits other
than bleeding control. One of these is decreased pain post operatively It is the
investigators belief that the use of a fibrin sealant, Tisseel, in cleft palate surgery will
decrease pain and enhance the recovery of children who undergo cleft palate repair.
The proposed study will randomly select children undergoing cleft palate repair to have
tisseel used on the incision. Through statistical tests 40 children will be recruited (20 to
have tisseel used and 20 with no tisseel). The use of tisseel will be known to the surgeon
but not to the recovery room or ward nursing staff. Post operatively, the FLACC pain scale
will be used to score the pain of the children throughout their admission to the Stollery
children's hospital. The amount of pain controlling medication required as well as time to
discharge will also be recorded. Statistical analysis of the data will be performed using
accepted methods. Overall, the investigators hope to show that fibrin sealant, tisseel, will
less the amount of post operative pain experienced by children undergoing cleft palate
repair.