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Keywords:

  • pain;
  • neonate;
  • cannulation;
  • Amethocaine;
  • local anaesthetics;
  • assessment double-blind study

No more tears: a randomized controlled double-blind trial of Amethocaine gel vs. placebo in the management of procedural pain in neonates

Aim. During a comparative double-blind study, the efficacy of Amethocaine local anaesthetic gel was compared with that of a placebo gel to establish their effect on the reduction of behavioural and physiological responses to pain in neonates.

Method. Forty infants were included in the trial, 20 being randomly assigned to each group. After topical application of either Amethocaine or the placebo for 30 minutes, cannulation was performed using a 24 gauge cannula. Assessment of pain was made with the aid of four point assessment tool incorporating facial expression, cry and heart rate changes and ease of cannulation. Additional baseline data were obtained including sex, gestation, weight and previous experience of cannulation, and analysed using Statistical Package for Social Sciences (SPSS).

Results. Good analgesic effects were demonstrated in the Amethocaine group, as there was a high level of significance (P < 0·01) in the difference in pain scores between the two groups using a Mann–Whitney U-test. There was no correlation between gestation or weight and the degree of pain experienced during painful procedures. No significant relationship was found between cannulation and the degree of pain experienced.

Conclusion. It can, therefore, be concluded that Amethocaine gel is an effective local anaesthetic in the management of skin puncturing procedural pain in neonates, and that all infants regardless of maturity, weight or previous experiences probably experience a similar degree of pain and therefore warrant effective and appropriate analgesic intervention.