A randomized controlled trial comparing Ametop™ with placebo for reducing pain associated with local anesthetic skin infiltration before neuraxial anesthesia in parturients.

Abstract:

BACKGROUND:Between 10-22% of the general population experience needle phobia. Needle phobic parturients are at increased risk of adverse outcomes. We assessed the efficacy of topical Ametop™ (tetracaine 4%) gel in reducing the pain associated with local anesthetic skin infiltration before neuraxial block in non-laboring women. METHODS:This was a prospective, randomized, double-blind, placebo-controlled study. Ametop™ or placebo was applied to the skin of the lower back at least 20min before neuraxial block using a standardized technique with 1% lidocaine skin infiltration. The primary outcome was numeric pain score (0-10) 30s after lidocaine infiltration. Groups were compared using Welch's t-test. RESULTS:Thirty-six subjects in each group were analyzed. There was a statistically significant difference in the mean (standard deviation) pain score between the Ametop™ and the placebo groups: 2.36±1.80 and 3.51±2.22, respectively (P=0.019). There were no significant adverse events. CONCLUSION:The mean numeric pain score in the Ametop™ group was 33% lower compared to the placebo group. Topical Ametop™ gel applied at least 20min before local anesthetic infiltration of the skin prior to neuraxial block in elective cesarean delivery may be a useful adjunct in needle phobic women.

journal_name

Int J Obstet Anesth

authors

Kavanagh T,Dube A,Albert A,Gunka V

doi

10.1016/j.ijoa.2016.03.005

subject

Has Abstract

pub_date

2016-08-01 00:00:00

pages

41-5

eissn

0959-289X

issn

1532-3374

pii

S0959-289X(16)00140-0

journal_volume

27

pub_type

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