Romantsik Olga, Calevo Maria Grazia, Norman Elisabeth, Bruschettini Matteo
Lund University, Skåne University Hospital, Department of Clinical Sciences Lund, Paediatrics, Lund, Sweden.
Istituto Giannina Gaslini, Epidemiology, Biostatistics Unit, IRCCS, Genoa, Italy, 16147.
Cochrane Database Syst Rev. 2020 Apr 9;4(4):CD013104. doi: 10.1002/14651858.CD013104.pub2.
Critically ill newborn infants undergo a variety of painful procedures or experience a variety of painful conditions during their early life in the neonatal unit. In the critically ill paediatric and neonatal population, clonidine is prescribed as an adjunct to opioids or benzodiazepines aiming to reduce the doses of these drugs that are required for analgesia or sedation, or to facilitate weaning from mechanical ventilation. It has been shown that clonidine premedication might have a positive effect on postoperative pain in children.
To assess the benefit and harms of clonidine for the prevention or treatment of procedural pain; postoperative pain; or pain associated with clinical conditions in non-ventilated neonates.
We used the standard search strategy of Cochrane Neonatal to search the CENTRAL, MEDLINE via PubMed, Embase, and CINAHL to December 2018. We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We ran an updated search from 1 January 2018 to 11 March 2020 in CENTRAL via CRS Web, MEDLINE via Ovid, and CINAHL via EBSCOhost.
Randomised controlled trials, quasi-randomised controlled trials, and cluster trials comparing clonidine to placebo or no treatment, opioids, paracetamol, dexmedetomidine, or non-pharmacological pain-reducing interventions for the management of procedural pain, postoperative pain, and pain associated with clinical conditions in preterm and term newborns.
Two review authors independently planned to extract data (e.g. number of participants, birth weight, gestational age, modality of administration, and dose of clonidine) and assess the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow-up). The primary outcome considered was pain: for procedural pain, the mean values of each analgesia scale assessed during the procedure and at one to two hours after the procedure; for postoperative pain and for pain associated with clinical conditions, the mean values of each analgesia scale assessed at 30 minutes, three hours, and 12 hours after the administration of the intervention. We planned to use the GRADE approach to assess the quality of evidence.
Our search strategy yielded 3383 references. Two review authors independently assessed all references for inclusion. We did not find any completed studies for inclusion. We excluded three trials where clonidine was administered for spinal anaesthesia.
AUTHORS' CONCLUSIONS: We did not find any studies that met our inclusion criteria and hence there is no evidence to recommend or refute the use of clonidine for the prevention or treatment of procedural or postoperative pain, or pain associated with clinical conditions in neonates.
危重新生儿在新生儿重症监护病房的早期生活中会经历各种痛苦的操作或遭受各种疼痛状况。在危重症儿科和新生儿群体中,可乐定被用作阿片类药物或苯二氮䓬类药物的辅助用药,旨在减少镇痛或镇静所需的这些药物剂量,或促进机械通气的撤机。已表明可乐定术前用药可能对儿童术后疼痛有积极影响。
评估可乐定预防或治疗操作疼痛、术后疼痛或未通气新生儿临床状况相关疼痛的获益与危害。
我们使用Cochrane新生儿组的标准检索策略,检索截至2018年12月的Cochrane系统评价数据库(CENTRAL)、通过PubMed检索的MEDLINE、Embase和护理学与健康领域数据库(CINAHL)。我们还检索了临床试验数据库、会议论文集以及检索到的随机对照试验和半随机试验文章的参考文献列表。我们于2018年1月1日至2020年3月11日在CENTRAL通过CRS Web、在MEDLINE通过Ovid以及在CINAHL通过EBSCOhost进行了更新检索。
比较可乐定与安慰剂或未治疗、阿片类药物、对乙酰氨基酚、右美托咪定或非药物性疼痛减轻干预措施,用于管理早产和足月新生儿操作疼痛、术后疼痛及临床状况相关疼痛的随机对照试验、半随机对照试验和整群试验。
两位综述作者独立计划提取数据(如参与者数量、出生体重、胎龄、给药方式和可乐定剂量)并评估偏倚风险(如随机化的充分性、盲法、随访完整性)。考虑的主要结局是疼痛:对于操作疼痛,为操作期间及操作后1至2小时评估的每种镇痛量表的平均值;对于术后疼痛和临床状况相关疼痛,为干预给药后30分钟、3小时和12小时评估的每种镇痛量表的平均值。我们计划使用GRADE方法评估证据质量。
我们的检索策略共获得3383条参考文献。两位综述作者独立评估所有参考文献以确定是否纳入。我们未找到任何符合纳入标准的已完成研究。我们排除了3项使用可乐定进行脊髓麻醉的试验。
我们未找到任何符合我们纳入标准的研究,因此没有证据推荐或反驳使用可乐定预防或治疗新生儿的操作或术后疼痛,或临床状况相关疼痛。