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新型丁卡因贴片用于接受静脉穿刺新生儿局部麻醉的随机试验。

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

作者信息

Long C P, McCafferty D F, Sittlington N M, Halliday H L, Woolfson A D, Jones D S

机构信息

School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.

出版信息

Br J Anaesth. 2003 Oct;91(4):514-8. doi: 10.1093/bja/aeg216.

DOI:10.1093/bja/aeg216
PMID:14504152
Abstract

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.

摘要

背景

静脉穿刺或足跟采血等操作会给新生儿带来疼痛,并可能导致相当大的压力。局部外用麻醉剂对静脉穿刺有效,但需要至少应用60分钟,且给药剂量会有所不同。我们评估了一种新型的基于丁卡因的自粘贴片在静脉穿刺前提供可控局部麻醉的效果。

方法

进行了一项安慰剂对照、双盲试验,使用由含丁卡因(1mg/cm²)的羟丙基纤维素圆盘(0.283cm²)制成的丁卡因贴片,周围是低粘性压敏粘合剂背衬层。32名孕周为32 - 42周(中位数36周)、年龄为3 - 18天(中位数6天)的新生儿被随机分为两组,在静脉穿刺前30分钟,一组接受含丁卡因的贴片,另一组接受安慰剂装置,均贴于手背以采集血样。使用经过验证的新生儿面部编码评分(NFCS)改编版和哭声情况来评估针刺时的疼痛程度。

结果

15名接受丁卡因治疗的新生儿中,14名(93%)在操作过程中表现出很少或没有疼痛,而接受安慰剂贴片的17名新生儿中有6名(35%)出现此情况(P = 0.01)。

结论

丁卡因贴片在足月儿和早产儿的静脉穿刺过程中均能有效缓解疼痛。且无局部或全身不良反应。

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