Randomized trial of novel tetracaine patch to provide local anaesthesia in neonates undergoing venepuncture.

BACKGROUND: Procedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are effective for venepuncture but need to be applied for at least 60 min and the delivered dose will vary. We assessed a novel tetracaine-based self-adhesive patch in providing controlled local anaesthesia before venepuncture. METHODS: A placebo-controlled, double-blind trial was conducted using a tetracaine patch formulated from hydroxypropylcellulose discs (0.283 cm(2)) containing tetracaine (1 mg x cm(-2)) surrounded by a low tack pressure-sensitive adhesive backing layer. Thirty-two newborn infants of gestation 32-42 weeks (median 36 weeks), aged 3-18 days (median 6 days) were randomized to receive a tetracaine-containing patch or a placebo device applied to the dorsum of the hand 30 min before venepuncture to obtain blood samples. Pain was assessed in response to needle insertion using a validated adaptation of the neonatal facial coding score (NFCS) and the presence of crying. RESULTS: Of 15 tetracaine-treated neonates, 14 (93%) presented little or no pain in response to the procedure compared with six of 17 (35%) who had the placebo patch applied (P=0.01). CONCLUSIONS: The tetracaine patch produced effective pain relief during the venepuncture procedure in both term and pre-term infants. There were no adverse effects, either local or systemic.

Surfactant replacement therapy for severe neonatal respiratory distress syndrome: implications for nursing care.

This study, which was part of a European multicentre randomised controlled trial of surfactant administration for severe respiratory distress syndrome, monitored the progress and nursing care of the group of babies enrolled in Belfast. In total 33 preterm babies with birth weights between 700-2000 g were studied. Nineteen babies were treated with surfactant and fourteen acted as controls, receiving conventional therapy with mechanical ventilation alone. All the babies had severe respiratory distress syndrome requiring mechanical ventilation in oxygen concentrations greater than 60% by the age of fifteen hours. The aim of the study was to determine the effect on nursing workload of giving surfactant to babies with severe respiratory distress syndrome. The duration of care, such as the length of time the babies required intensive care and subsequent hospitalisation was calculated for each baby. The characteristics of the treated and control babies were similar but survival in the treated group was significantly greater (79% vs 36%, p less than 0.05). There were no significant differences between the groups for individual nursing requirements. However due to the increase in numbers of surviving surfactant treated babies there was a threefold increase in cumulative nursing workload. Surfactant replacement therapy effectively modifies the course of respiratory distress syndrome but also increases the nursing workload and the need for intensive care. This has implications for staffing and financial support of Neonatal Intensive Care Units once surfactant replacement becomes a routine treatment.