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British Journal of Anaesthesia, 2003, Vol. 91, No. 4 514-518
© 2003 The Board of Management and Trustees of the British Journal of Anaesthesia

Clinical Investigations

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

C. P. Long*,1, D. F. McCafferty{dagger},1, N. M. Sittlington2, H. L. Halliday2,3, A. D. Woolfson1 and D. S. Jones1

1 School of Pharmacy, Queen’s University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK. 2 Regional Neonatal Unit, Royal Maternity Hospital, Grosvenor Road, Belfast BT12 6BB, UK. 3 Department of Child Health, Queen’s University Belfast, Institute of Clinical Science, Grosvenor Road, Belfast BT12 6BJ, UK

Corresponding author. E-mail: c.long@qub.ac.uk
{dagger}Deceased before completion of the study.

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 cm2) containing tetracaine (1 mg 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.

Br J Anaesth 2003; 91: 514–18


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