A Systematic Review of the Efficacy of Haemostatic Interventions in Primary Cleft Palate Repair.

Objective: To evaluate the effectiveness of adrenaline infiltration, topical adrenaline, systemic tranexamic acid, fibrin tissue sealants and alginate-based topical coagulants at reducing blood loss and post-operative bleeding in primary cleft palate repair.

Design: Systematic review according to PRISMA-P guidelines, using Covidence systematic review software to facilitate 3-stage screening and data extraction by two reviewers.

Setting: Academic cleft surgery center.

Interventions: Any peri-operative intervention to reduce intra-operative and post-operative bleeding.

Main Outcome Measures: Estimated blood loss, rate of post-operative bleeding, rate of return to theatre for haemostasis.

Results: Sixteen relevant studies were identified, with a total of 1469 study participants. Nine studies examined efficacy of infiltrating vasoconstrictors and all concluded that 1:100,000-1:400,000 adrenaline infiltration reduced intra-operative blood loss, to the range of 12-60 ml. Secondary bleeding and re-operation for haemostasis were uncommon. Tranexamic acid was studied in five randomised controlled trials, two of which demonstrated a significant reduction in blood loss compared to a control group. Use of fibrin and gelatin sponge products was examined in 3 studies, all of which reported no or minimal bleeding, but did not have quantifiable outcome measures.

Conclusions: Infiltration with vasoconstricting agents, administration of systemic tranexamic acid and application of fibrin sealants have a well-studied and favorable safety profile in pediatric cases, and likely contribute to the relatively low incidence of post-operative bleeding and intra-operative blood loss in primary cleft palate repair.