Overview

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:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Alberta

Treatments:

Fibrin Tissue Adhesive

Criteria

Inclusion Criteria:

- Undergoing primary cleft palate repair (palatoplasty)

- Informed consent from parent(s) or guardian(s)

Exclusion Criteria:

- Allergy to any component of Tisseel

- failure to obtain informed consent