Effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after deep sedation, in upper GI endoscopy in pediatric patients

ِDeterminig the effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after deep sedation, in upper GI endoscopy in pediatric patients

Randomized, parallel group trial with blinded outcome assessment and postoperative care.

Based on the inclusion and exclusion criteria, 98 children aged 2 to 14, candidate for an elective upper GI endoscopy are selected, and after an informed consent is obtained from their parents, are randomly divided into 2 groups. In both groups standard monitoring devices will be installed. after preoxigenation with 100% O2, anesthesia is induced with 2.5 mg/kg thiopental and deepened with Sevoflurane. Preopertively, in the intervention group 0/1 mg/kg IV Dexamethasone and in the control, same volume of IV normal saline will be administered. Postoperatively, data on incidence of Nausea/vomiting and other outcomes will be collected in the recovery room, by an investigator who is blinded to the intervention allocation.

Inclusion criteria: All 2 to 14 year-old children, who are a candidate for an elective upper GI endoscopy, and whose parents have given an informed consent; Exclusion criteria: Patients with a history of hypersensitivity to the drugs studied, metabolic disease or diabetes, anatomical upper airway disorders, Patients diagnosed with behavioral disorders or currently taking psychiatric medication, patients who have previously undergone chemotherapy or have taken a sedative/hypnotic drug prior to endoscopy, Patients who are a candidate for an emergency endoscopy or whose operation is complicated and takes too long to be completed

For intervention group 0/1 mg/kg IV Dexamethasone, and for the control, same volume of IV normal saline will be administered before operation.

Incidence of nausea/vomiting after endoscopy

A statistical computer program is used to make random block stratified individual assignments with user selected block sizes. The psuedonumber generator is a linear congruential algorithm of Park and Milller with Bays-Durham shuffling. The random sheets will be given directly to nurse administrating the drugs and neither the participants nor the researcher collecting the data will be informed of the method of drug allocation to patients.

The randomly allocated list of patients will be given exclusively to the nurse administrating the drugs. Participants, gastroenterologist performing endoscopy, attending anesthesiologist, recovery nurse and the researcher collecting data will not be informed of the method of drug allocation to patients. (The parents of participants will be thoroughly informed that this clinical trial uses a randomized method before giving consent)

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.