经口投予oxycodone有助于孩童的急性腹痛


  April 4, 2005 - 一项刊载于四月份小儿及青少年医学志(Archives of Pediatric and Adolescent Medicine)的随机分配研究结果显示,经口腔投予oxycodone可以对孩童的急性腹痛作有效的舒缓,并且不会将诊断模糊化。
  
  芬兰Kuopio大学医院的Hanuu Kokki医师表示,根据外科医学的传统,对于急性腹痛的孩童患者,必须要等到医师们确立了治疗法以后,才得以使用止痛剂;止痛剂据称会掩盖症状,影响生理检查结果,延缓诊断,并导致死亡率的增加;近年来,这项传统的认知已遭到挑战。
  
  本研究为一先期性、双盲性的试验,共有104位4到15岁的孩童参与,皆在2001年12月至2003年11月间被筛检出患有腹痛症状;这些患者的疼痛期都在7天以内,其中的63位因为目视疼痛指数超过5,因此被纳入本次的试验中。
  
  孩童们被以随机的方式投予舌下oxycodone hydrochloride 0.1 mg/kg,或等量的生理食盐水;在第一次剂量投予前,1小时及3.5小时后,由同一位医师对参试者作身体检查、临时性诊断及临时性的病况判定;在第一次剂量的试验期中,每隔30分钟做一次疼痛指数的纪录,基线时也纪录一次,如此持续3.5小时;主要的效果指标,为疼痛程度的差异、有无腹部紧缩的状况及诊断的精确度等。
  
  两组孩童的人口学特质皆类似,其它的相似点还有初始的疼痛状况、生理征兆及症状;两项药物皆降低了疼痛指数,但是在经过了7次的观察后发现,Oxycodone组,在疼痛程度上有著较高的差异,安慰剂组则明显较低(22± 18cm vs 9± 12cm)。
  
  在药物投予后,Oxycodone组的诊断精确度从72%升至88%,安慰剂组则维持在84%;Oxycodone组中有17位,安慰剂组中有14位进行了腹腔镜手术;即使无盲肠炎,两组各有4位接受了探究性的腹腔镜手术;虽然安慰剂组中有一位在初诊时发现有非特定性的腹痛,但是该患者在经过14个小时后即接受阑尾穿刺手术。
  
  Kokki医师表示,急性腹痛的孩童可以藉由舌下oxycodone的提早使用,而得到明显的缓解,且不会负面的改变临床征兆,或将外科诊断模糊化;然而,这类的鸦片类药物并不会导致任何严重的副作用,或其它难以应付的后果。
  
  研究的限制因素,包含每一位孩童的试验前及试验后诊断皆由同一位医师进行,这可能会导致误差;无法将试验结果适用至一般的门诊患者;样本过小;在医师进行评估之前,无法决定是否对剧痛的孩童给予止痛剂。
  
  Kokki医师总结指出,更大型试验的进行将受到本研究结果的支持,以便进一步评估这项疗法的安全性,并探究腹部手术是否会因止痛剂的提早使用而受到影响。

Buccal Oxycodone May Be Helpfu

By Laurie Barclay, MD
Medscape Medical News

April 4, 2005 — Buccal oxycodone provides reasonable pain relief for children with acute abdominal pain without obscuring the clinical diagnosis, according to the results of a randomized study published in the April issue of the Archives of Pediatric and Adolescent Medicine.

"Classic teaching in surgery has dictated that the use of analgesics should be withheld from children with acute abdominal pain until a surgeon establishes a definitive treatment plan," write Hannu Kokki, MD, from Kuopio University Hospital in Finland, and colleagues. "It has been claimed that analgesia masks symptoms and physical findings, delays diagnosis, and leads to increased morbidity. Over the past few years, this traditional belief has been challenged."

In this prospective, double-blind trial, 104 children aged 4 to 15 years with abdominal pain of less than seven days' duration were screened between December 2001 and November 2003, and 63 children with pain scores of five or higher on a 10-cm visual analog scale were eligible for the trial.

Children were randomized to receive buccal oxycodone hydrochloride, 0.1 mg/kg, or the same volume of normal saline. The same surgeon determined the physical findings, provisional diagnosis, and provisional disposition before the children received the study medication and at one hour and 3.5 hours after initial dosing. After the first study drug administration, pain scores were recorded at baseline and every 30 minutes for 3.5 hours. Primary outcomes were pain intensity difference, presence or absence of abdominal guarding, and diagnostic accuracy.

Both groups were similar in terms of demographic characteristics, initial pain scores, and physical signs and symptoms. Pain scores decreased with both study drugs. However, the summed pain intensity difference for seven observations was significantly greater in the oxycodone group (22 ± 18 cm) than in the placebo group (9 ± 12 cm; mean difference, 13 cm; 95% confidence interval, 2 - 24 cm; P = .04).

After study drug administration, diagnostic accuracy increased from 72% to 88% in the oxycodone group and remained at 84% in the placebo group. Laparotomy was performed in 17 patients in the oxycodone group and in 14 patients in the placebo group, and four patients in each group underwent exploratory laparotomy despite the absence of appendicitis. Although one patient in the placebo group initially was diagnosed as having nonspecific abdominal pain, the patient underwent surgery at 14 hours for appendiceal perforation.

"Early administration of buccal oxycodone provides a significant pain relief to children with acute abdominal pain, without adversely altering the clinical signs or obscuring the surgical diagnosis," the authors write. "Moreover, no serious adverse effects or any major untoward outcomes occurred in association with the opioid administration."

Study limitations include the same surgeon performing the prestudy medication and poststudy medication examinations for each child, causing potential bias; inability to generalize these results to outpatients; small sample size; and inability to determine whether children with severe pain could be given analgesia before the surgeon's evaluation.

"Results of this trial support a large scale trial to further evaluate whether this approach is safe and whether early analgesic treatment affects the ability to diagnose a surgical abdomen," the authors conclude.

Arch Pediatr Adolesc Med. 2005;159:320-325

Reviewed by Gary D. Vogin, MD

    
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