Which restraint should be used for an infant after a cleft palate repair?

Following surgery for cleft lip and palate, and other surgeries on the face, arm restraints are used so that your child will not disrupt the sutures places at the time of surgery. Please bring the arm restraints with you to your child’s clinic appointments following surgery.

The UNC Pediatric and Craniofacial Group Give Back Program encourages families to return their children’s arm restraints after surgery. These arm restraints are valuable and can be used by families overseas following free surgeries done by UNC surgeons. Please remember to donate your child’s arm restraints after surgery!

Purpose. This study examines whether the use of elbow restraints after cleft lip/palate repair has a relationship to postoperative complications. Methods. A comparative descriptive design was used to study a convenience sample of children undergoing repair of cleft lip/palate at Akron Children’s Hospital with Institutional Review Board approval. The children were randomized into intervention or control groups with use of elbow restraints considered the intervention. The study consists of two arms; one examined children after cleft lip repair, the second examined children after cleft palate repair. Repairs were performed by a single surgeon. Data collected included age, comorbidities, patient discomfort measured by pain score, frequency and duration of pain medications, use of pacifier or finger/thumb sucking, and postoperative complications including disruption of the suture line. Results. With 47 post palate repair patients and 47 post cleft repair patients, there is no significant difference [] in the occurrence of postoperative complications. Conclusions. Study results provide prospective evidence to support postoperative observation of children by surgery staff and family following cleft lip or cleft palate repair without the use of elbow restraints. Clinicians should reevaluate the use of elbow restraints after cleft lip/palate repair based on the belief restraints prevent postoperative complications.

1. Introduction

The question of whether children require elbow restraints following cleft lip and palate repair is unresolved. The theory is that arm restraints prevent children from putting their fingers or objects into their mouth where they could disrupt the suture line. In a survey of plastic surgeons in the United Kingdom in 1993, 93% of plastic surgeons reported the use of arm restraints after repair [1]. Other reports also support the use of splints [2, 3].

In the United States, the use of arm restraints remains a part of the dogma. A survey of Cleft Palate Teams by Petersen [4] in 2008, showed 95% of respondents advocated postoperative arm restraints. A publications by Katzel et al. [5] in 2009, on current surgical practices in cleft care stated that 85% of cleft surgeons recommended the use of elbow restraints after surgery.

This approach has been generally accepted as good practice; however, Jiginni et al. [1] in 1993 found no statistically significant difference between the use or nonuse of arm restraints in the development of postoperative complications. This is the only evidence-based evaluation in the medical literature. With family centered care practiced in the majority of pediatric hospitals parents should be given evidence-based medical results in order to be able to make informed decision on the use of restraints for their child postoperatively.

On this basis we conducted a prospective clinical trial to bridge the gap that still remains between practice and evidence based medicine in the use of arm restraints to prevent postoperative complications following cleft lip and palate repair.

2. Method

A comparative descriptive design was used to study a prospective sample of children undergoing repair of cleft lip/palate at our pediatric teaching hospital by a single surgeon. The study consisted of two arms. One arm examined children after cleft lip repair; the second arm examined children after repair of cleft palate. All cleft lip patients had a Millard rotation advancement repair, and all cleft palate patients had an intravelar veloplasty repair. All parents of children under the age of 2 who were scheduled for repair of their cleft lip or cleft palate by the study author were invited to give consent to enter their child in the study. Children who required transfer to the critical care setting were excluded from the study. The study received IRB approval.

Because the use of arm restraints is thought to protect the incision from damage infants can cause by placing their fingers/thumb in or at their mouth, we included children whose parents reported them to be finger, thumb, or pacifier suckers in both the cleft lip and the cleft palate repair groups.

The data collected included the child’s age, gender, type of cleft repair [lip or palate], preoperative thumb, finger, or pacifier sucking, and the existence of any comorbidity. During hospitalization in the postoperative phase, antibiotic therapy, frequency of pain medications, premedication flacc pain scores, length of hospital stay in days, and an every four hour assessment of the operative site for excessive bleeding or indication of infection were recorded. Phone calls to the parents were made at one week postcleft lip or palate repair. Parents were asked to identify any disruption of the suture line such as a broken stitch or separation of the wound, excessive bleeding from the mouth or nose, signs of infection including redness, edema, drainage, or fever, and the child’s discomfort reported as the average flacc pain score and frequency of pain medications at one week postoperatively. These questions were also asked of the parents at the followup office visit where standardized photographs were taken of the surgical site, and documentation of any disruption of the suture line was noted by the surgeon.

Participants were divided into a control group, which used restraints, or into the intervention group, with no use of arm restraints. This assignment occurred as they entered the PACU following repair and after receiving parental consent. Assignment to the intervention or control group was alternated every other child. The study procedures were reviewed with parents/guardians in the postanesthesia care unit. This included the deviations from usual care which included the absence of arm restraints in the intervention group and a followup phone call to the home of all participants. Other than the use of restraints, each group received the same standard of care. After signing the consent, parents were given a copy of the study procedures and researchers’ contact information. Data collection continued on the nursing care units with assessments of the surgical site recorded every four hours. Educational materials on the study protocol were presented to nursing staff and maintained on each unit to facilitate competency among nurse data collectors. A copy of the flacc pain scale [Merkel et al., 1997] [6] was reviewed with parents in the PACU and included in the home going instruction packet to parents. This aided parents in communicating a pain score assessment and use of pain medications with the nurse during the one-week postoperative phone call. Assessment of the surgical site and any complications were noted by the surgeon and office staff at the postoperative office visit.

3. Results

A total of 47 children were enrolled in the cleft lip repair arm of the study, and 47 children were enrolled in the cleft palate repair group [Table 1]. Twenty one of the children enrolled in the control group of the cleft lip repair arm had good [] to excellent [] postoperative healing of the surgical site. Twenty-six children enrolled in the intervention or no arm restraint group of the cleft lip repair arm demonstrated good [] to excellent [] repair. Families of 2 children in the intervention group did not return for followup evaluation.

Table 1 

Demographics of patients.

The surgical outcome in cleft lip repair was initially evaluated by our surgical nurse and the surgeon. Postoperative photos at 6 months were then used as a final evaluation. Excellent results had no off set of the vermilion and no elevation of the lip on the cleft side. Good results had minor vermilion offset [