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Open Access Research article

How effective is tetracaine 4% gel, before a peripherally inserted central catheter, in reducing procedural pain in infants: a randomized double-blind placebo controlled trial [ISRCTN75884221]

Brigitte Lemyre1*, Rebecca Sherlock2, Debora Hogan3, Isabelle Gaboury4, Colline Blanchard5 and David Moher146

Author Affiliations

1 Department of Pediatrics, Children's Hospital of Eastern Ontario, 401, Smyth Road, Ottawa, Ontario, Canada

2 Department of Pediatrics, BC Children's and Women's Health Center, 4480, Oak Street, Vancouver, BC, Canada

3 Department of Nursisn, Hospital of Eastern Ontario, 401, Smyth Road, Ottawa, Ontario, Canada

4 Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, 401, Smyth Road, Ottawa, Ontario, Canada

5 Department of Pharmacy, Children's Hospital of Eastern Ontario, 401, Smyth Road, Ottawa, Ontario, Canada

6 Department of Epidemiology & Community Medicine, Faculty of Medicine, University of Ottawa, Canada

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BMC Medicine 2006, 4:11  doi:10.1186/1741-7015-4-11

Published: 3 May 2006

Abstract

Background

Procedural pain relief is sub-optimal in infants, especially small and vulnerable ones. Tetracaine gel 4% (Ametop®, Smith-Nephew) provides pain relief in children and larger infants, but its efficacy in smaller infants and for peripherally inserted central catheters (PICC) remains uncertain. The objective of this trial was to assess the safety and efficacy of tetracaine gel on the pain response of very low birth weight (VLBW) infants during insertion of a PICC.

Methods

Medically stable infants greater than or equal to 24 weeks gestation, requiring a non-urgent PICC, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. The PICC was inserted according to a standard protocol. Pain was assessed using the Premature Infant Pain Profile (PIPP). A 3-point change in the pain score was considered clinically significant, leading to a sample size of 54 infants, with 90% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test.

Results

Fifty-four infants were included, 27 +/- 2 weeks gestation, 916 +/- 292 grams and 6.5 +/- 3.2 days of age. Baseline characteristics were similar between groups. The mean PIPP score in the first minute was 10.88 in the treatment group as compared to 11.74 in the placebo group (difference 0.86, 95% CI -1.86, 3.58). Median duration of crying in non-intubated infants was 181 seconds in the tetracaine group compared to 68 seconds in the placebo group (difference -78, 95% CI -539, 117). Local skin erythema was observed transiently in 4 infants (3 in the treatment and 1 in the placebo group). No serious harms were observed.

Conclusion

Tetracaine 4% when applied for 30 minutes was not beneficial in decreasing procedural pain associated with a PICC in very small infants.