Slater Rebeccah, Hartley Caroline, Moultrie Fiona, Adams Eleri, Juszczak Ed, Rogers Richard, Norman Jane E, Patel Chetan, Stanbury Kayleigh, Hoskin Amy, Green Gabrielle
Department of Paediatrics, University of Oxford, Oxford, UK.
National Perinatal Epidemiology Unit (NPEU), University of Oxford, Oxford, UK.
Wellcome Open Res. 2016 Nov 15;1:7. doi: 10.12688/wellcomeopenres.10005.2.
Infant pain has both immediate and long-term negative consequences, yet in clinical practice it is often undertreated. To date, few pain-relieving drugs have been tested in infants. Morphine is a potent analgesic that provides effective pain relief in adults, but there is inconclusive evidence for its effectiveness in infants. The purpose of this study is to establish whether oral morphine provides effective analgesia for procedural pain in infants. A blinded, placebo-controlled, parallel-group randomized, phase II, clinical trial will be undertaken to determine whether morphine sulphate administered orally prior to clinically-required retinopathy of prematurity (ROP) screening and heel lancing provides effective analgesia. 156 infants between 34 and 42 weeks' gestational age who require a clinical heel lance and ROP screening on the same test occasion will be included in the trial. Infants will be randomised to receive either a single dose of morphine sulphate (100 μg/kg) or placebo. Each infant will be monitored for 48 hours and safety data will be collected during the 24 hours following drug administration. The primary outcome will be the Premature Infant Pain Profile-revised (PIPP-R) score 30 seconds after ROP screening. The co-primary outcome will be the magnitude of nociceptive-specific brain activity evoked by a clinically-required heel lance. Infant clinical stability will be assessed by comparing the number of episodes of bradycardia, tachycardia, desaturation and apnoea, and changes in respiratory support requirements in the 24-hour periods before and after the clinical intervention. In addition, drug safety will be assessed by considering the occurrence of apnoeic and hypotensive episodes requiring intervention in the 24-hour period following drug administration. This study has been published as an by .
婴儿疼痛会产生即时和长期的负面后果，但在临床实践中其往往未得到充分治疗。迄今为止，很少有止痛药物在婴儿身上进行过测试。吗啡是一种强效镇痛药，能在成人中有效缓解疼痛，但关于其在婴儿中的有效性证据尚无定论。本研究的目的是确定口服吗啡对婴儿程序性疼痛是否具有有效的镇痛作用。将进行一项双盲、安慰剂对照、平行组随机、II期临床试验，以确定在临床上需要进行早产儿视网膜病变（ROP）筛查和足跟采血之前口服硫酸吗啡是否能提供有效的镇痛效果。
该试验将纳入156名胎龄在34至42周之间、在同一测试时机需要进行临床足跟采血和ROP筛查的婴儿。婴儿将被随机分为接受单剂量硫酸吗啡（100μg/kg）或安慰剂。对每个婴儿进行48小时监测，并在给药后的24小时内收集安全数据。主要结局将是ROP筛查后30秒的修订版早产儿疼痛量表（PIPP-R）评分。共同主要结局将是临床要求的足跟采血诱发的伤害性特异性脑活动强度。通过比较临床干预前后24小时内心动过缓、心动过速、血氧饱和度下降和呼吸暂停发作的次数以及呼吸支持需求的变化来评估婴儿的临床稳定性。此外，通过考虑给药后24小时内需要干预的呼吸暂停和低血压发作的发生情况来评估药物安全性。本研究已作为一篇……发表。
