The effects of ondansetron, dexamethasone and the combination of these two drugs in reducing nausea and vomiting in children

Comparison of prophylactic effect of ondansetron, dexamethasone, combination of these drugs and placebo on decreasing nausea and vomiting in children aged 1 to 12 years undergoing upper gastrointestinal endoscopy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160307026950N7

Enrollment

144

Registered

2018-07-13

Start date

2016-01-21

Completion date

Unknown

Last updated

2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nausea and vomiting. Nausea and vomiting

Interventions

Intervention 1: The intervention group (o): First, informed consent is obtained from the child's parents. After placement of the patients on the bed and attaching standard monitoring devices including

Eligibility

Sex/Gender

All

Age

1 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged 1 to 12 years old ASA I and II candidates for upper gastrointestinal tract endoscopy parental consent for participation in the study

Exclusion criteria

Exclusion criteria: History of allergy to study drug Severe respiratory disease Severe cardiovascular disease uncontrolled diseases

Design outcomes

Primary

Measure	Time frame
Heart rate. Timepoint: Before the intervention (0), then every 5 minutes until the end of endoscopy and then every 15 minutes until discharge the recovery. Method of measurement: Pulse oximetry device.;Nausea and vomiting. Timepoint: Every 15 minutes in recovery room, and then 2, 4 and 6 hours after endoscopy. Method of measurement: Baxter Retching Face Nausea Scale.;Mean arterial blood pressure. Timepoint: Before the intervention (0), then every 5 minutes until the end of endoscopy and then every 15 minutes until discharge the recovery. Method of measurement: non invasive blood pressure sphygmomanometer.;Arterial oxygen saturation. Timepoint: Before the intervention (0), then every 5 minutes until the end of endoscopy and then every 15 minutes until discharge the recovery. Method of measurement: Pulse oximetry device.	—

Measure

Time frame

Heart rate. Timepoint: Before the intervention (0), then every 5 minutes until the end of endoscopy and then every 15 minutes until discharge the recovery. Method of measurement: Pulse oximetry device.;Nausea and vomiting. Timepoint: Every 15 minutes in recovery room, and then 2, 4 and 6 hours after endoscopy. Method of measurement: Baxter Retching Face Nausea Scale.;Mean arterial blood pressure. Timepoint: Before the intervention (0), then every 5 minutes until the end of endoscopy and then every 15 minutes until discharge the recovery. Method of measurement: non invasive blood pressure sphygmomanometer.;Arterial oxygen saturation. Timepoint: Before the intervention (0), then every 5 minutes until the end of endoscopy and then every 15 minutes until discharge the recovery. Method of measurement: Pulse oximetry device.

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Secondary

Measure	Time frame
Duration of stay in recovery. Timepoint: From recovery admission to recovery discharge. Method of measurement: Watch or clock.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Jafari

Esfahan University of Medical Sciences

fatemejfr1991@gmail.com+98 31 3668 0048

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026