Antiemetic effect of Dexamethasone in pediatric endosocopy

Phase 3

Conditions: Post endoscopy nausea and vomiting.
Nausea and vomiting

Registration Number: IRCT20180929041173N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Objectives: We aimed to evaluate the effect of a single dose of preoperative dexamethasone on postoperative nausea and vomiting (PONV), a frequent complication and a major cause of delayed recovery in pediatric upper gastrointestinal endoscopy (UGIE) under sedation. Methods: In this double-blind randomized controlled study, 98 children aged 2 to 14, with American Society of Anesthesiologists status I to II, and undergoing elective UGIE with deep sedation were included and randomly assigned to 2 groups. Preoperatively, after anesthesia induction with sodium thiopental and maintenance with sevoflurane, patients in the intervention (n = 49) and control (n = 49) groups, respectively received 0.1 mg/kg i.v. dexamethasone and 2 cm3 i.v. 0.9% saline. Postoperatively, PONV incidence was measured as the primary outcome. Results: PONV incidence was significantly less in dexamethasone group (8.2%) compared to the control group (26.5%) (difference = 18.3%, 95% confidence interval: 3.4%-33%, P = 0.016). For secondary outcomes, between-group differences were not statistically significant: incidence of bronchospasm or laryngospasm (both 4.1%, P = 1); emergence delirium assessed with Pediatric Anesthesia Emergence Delirium scale (5.9 ± 3.4 vs 5.7 ± 3.2, P = 0.751); Modified Aldrete score at 0 minutes (9.4 ± 0.8 vs 9.3 ± 0.9, P = 0.909) and at 5 minutes (9.5 ± 0.7 vs 9.4 ± 0.9, P = 0.527); and recovery time (21.1 ± 6.6 vs 23.4 ± 8.6 minutes, P = 0.130). Conclusions: A single preoperative dose of i.v. dexamethasone reduces PONV in children undergoing elective UGIE with deep sedation, but has no significant effect on the patient recovery time or the incidence of postoperative bronchospasm or laryngospasm and emergence delirium.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 98

Inclusion Criteria

All 2 to 14 year-old children, candidate for an elective upper GI endoscopy, according to the pediatric gastroenterologist diagnosis

Exclusion Criteria

Patients with a history of hypersensitivity to the drugs studied
Patients with a history of metabolic disease or diabetes
Patients with anatomical upper airway disorders
Patients diagnosed with behavioral disorders or currently taking psychiatric medication
Patients with a history of undergoing chemotherapy
Patients who have taken a sedative/hypnotic drug prior to endoscopy
Patients who are a candidate for an emergency endoscopy
Patients whose operation is complicated (e.g. by bleeding) and takes too long to be completed
Patients without a parental informed consent

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of nausea/vomiting. Timepoint: Recording the incidence of nausea/vomiting, evaluated during patients' stay in the post-anesthesia recovery room. Method of measurement: Investigator evaluation and examination.

Secondary Outcome Measures