A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management.

Background And Aims: Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project.

Quality differences in postoperative sleep between propofol-remifentanil and sevoflurane anesthesia in infants.

Background: Postoperative behavioral disorders are common in children, but the occurrence in infants is not yet clear. In the present study we focus on postoperative sleep disturbances, which we hypothesized would be more common after sevoflurane anesthesia than propofol-remifentanil anesthesia.

Methods: In total, 39 infants 4-6-mo-old were prospectively enrolled and randomized to receive either a combination of propofol and remifentanil (n = 17) or sevoflurane and fentanyl anesthesia (n = 22) for surgical repair of cleft lip-gum-palate.