Timmerman Marjolijn E W, Trzpis Monika, Broens Paul M A
Division of Pediatric Surgery, Department of Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Department of Surgery, Anorectal Physiology Laboratory, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
BMJ Paediatr Open. 2018 Nov 9;2(1):e000341. doi: 10.1136/bmjpo-2018-000341. eCollection 2018.
Many children with acute abdominal pain and suspicion of appendicitis are diagnosed with constipation. Nevertheless, it can be difficult to differentiate between acute constipation and acute appendicitis because of similar symptoms and lack of diagnostic criteria. Consequently, constipation is often missed despite repeated consultations at the emergency department. We hypothesise that the diagnostic process can be improved and adequate treatment accelerated by supporting faecal evacuation in children with acute abdominal pain.
An unblinded randomised controlled trial including children aged between 5 years and 18 years with acute abdominal pain and suspicion of acute appendicitis. Children who do not have a definitive diagnosis after the first consultation and who need to return for a second consultation will be randomised. The intervention group will receive laxatives and enemas, while the control group will receive no medication. If, after the second consultation, still no diagnosis is established, and a third consultation is needed, then the intervention group will receive only laxatives, and the control group will again not receive medication. The primary outcome will be the differences in abdominal pain scores obtained with FACES Pain Rating Scale and the visual analogue scale at first, second and possibly third consultation. The secondary outcome will be the number of consultations needed to reach final diagnosis.
Laxatives and enemas have proven to be safe and effective treatments for constipation in children. Adverse events are therefore not expected, however, should they occur, then the child concerned shall be properly followed and treated until the event is over. The local Medical Research Ethics Committee approved of this study and waived the otherwise mandatory insurance for human test subjects.
Pre-results: CCMO NL44710.042.12 andEudraCT 2013-000498-56.
许多患有急性腹痛且疑似阑尾炎的儿童被诊断为便秘。然而，由于症状相似且缺乏诊断标准，很难区分急性便秘和急性阑尾炎。因此，尽管在急诊科多次就诊，便秘仍常常被漏诊。我们推测，通过支持急性腹痛儿童的粪便排出，可以改善诊断过程并加速适当治疗。
一项非盲随机对照试验，纳入5至18岁患有急性腹痛且疑似急性阑尾炎的儿童。首次就诊后未明确诊断且需要再次就诊的儿童将被随机分组。干预组将接受泻药和灌肠剂，而对照组不接受任何药物治疗。如果第二次就诊后仍未确诊且需要第三次就诊，那么干预组将仅接受泻药治疗，对照组仍不接受药物治疗。主要结局将是在第一次、第二次以及可能的第三次就诊时，使用面部表情疼痛评分量表和视觉模拟量表获得的腹痛评分差异。次要结局将是达到最终诊断所需的就诊次数。
泻药和灌肠剂已被证明是治疗儿童便秘的安全有效方法。因此预计不会出现不良事件，然而，如果发生不良事件，将对相关儿童进行适当随访和治疗，直至事件结束。当地医学研究伦理委员会批准了本研究，并免除了对人体试验对象的强制保险。
结果前：CCMO NL44710.042.12和欧洲临床试验数据库编号2013-000498-56。
