Oral Lorazepam is not Superior to Placebo for Lowering Stress in Children Before Digestive Endoscopy: A Double-Blind, Randomized, Controlled Trial

Abstract

Digestive endoscopies must be performed within a safe and comfortable environment. We have previously shown that the quality of intravenous sedation is influenced by preoperative stress. Our primary objective was to compare the effects of oral lorazepam and placebo on the salivary cortisol response of children undergoing a digestive endoscopy. Secondary objectives were the assessment of procedural pain and comfort as well as the occurrence of adverse events. Participants were randomized and received either lorazepam, placebo, or no premedication. Saliva was collected upon arrival at the hospital and 1 h following randomization. The sedation protocol included midazolam and fentanyl\u2009±\u2009ketamine. Procedural pain was evaluated with the Nurse Assessed Patient Comfort Score (NAPCOMS). Patients completed a postoperative questionnaire. The primary outcome was defined as the proportion of children having a cortisol decrease\u2009≥\u200915 nmol/L. 101 participants (54 females) were included. The rate of children having a cortisol decrease\u2009≥\u200915 nmol/L was 27.3%, 35.3%, and 19.4% for lorazepam, placebo, and no premedication, respectively (p\u2009=\u20090.356). The median (IQR) NAPCOMS pain score was 3.0 (0–6) for lorazepam, 4.4 (0–6) for placebo, and 3.4 (3–4) for no premedication (p\u2009=\u20090.428). With lorazepam, 75.9% of children reported experiencing a comfortable procedure, compared with 41.9% taking placebo and 34.5% with no premedication (p\u2009=\u20090.013). Transient tachycardia was the most frequent intraoperative adverse event, particularly with lorazepam (62.5%, p\u2009=\u20090.029). Oral lorazepam had no effect on patients’ preoperative stress, as measured by salivary cortisol, but was associated with a higher rate of comfortable procedures. Clinicaltrials.gov, Identifier NCT03180632.