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Treatment of Nausea and Vomiting in Head Trauma

Comparison of the Effect of Ondansetron and Metoclopramide in Treatment of Nausea and Vomiting in Head Trauma Patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017010231731N1
Enrollment
130
Registered
2017-01-21
Start date
2016-09-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Head Trauma. Superficial injury of head

Interventions

Intervention group 2: Intravenous Ondansetron, 4mg/2ml, Once injection
Intervention group 1: Intravenous Metoclopramide, 10 mg/2ml once injection
Intervention 1: Intervention group 1: Intravenous Metoclopramide, 10 mg/2ml once injection. Intervention 2: Intervention group 2: Intravenous Ondansetron, 4mg/2ml, Once injection.
Treatment - Drugs

Sponsors

Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: History of head trauma; Presence of nausea or vomiting; Triage level of 3 or more; GCS >=13, age over 15. Exclusion criteria: Unstable hemodynamics; Pregnancy or breast feeding; Neurologic deficit; Restless leg syndrome; Alcoholism; Prior use of antiemetics within 8 hours; Opioid use; Prior intravenous fluid administration; Vertigo; Chemotherapy; Radiotherapy; History of allergy or adverse reaction to metoclopramide or ondansetron; inability to complete trial or record outcomes.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Nausea / Vomiting. Timepoint: Before and 20 minutes after injection. Method of measurement: VAS score (visual analog scale).

Secondary

MeasureTime frame
Drug adverse effect including extrapyramidal effects, dyskinesia. Timepoint: at discharge. Method of measurement: clinical exam.;Need for repeating injection. Timepoint: 20 minutes after first injection. Method of measurement: VAS score (Visual Analog Scale).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHosein Partovinejad

Shahid Beheshti University of Medical Sciences

biglari-m@razi.tums.ac.ir+98 21 73430

Outcome results

None listed

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