Vomiting in Infants and/or ChildrenNCT05076461
Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children
A study testing Ondansetron in people with Vomiting in Infants and/or Children and Acute Gastroenteritis, run by Tehsil Headquarter Hospital at 1 site in Pakistan.
Trial summary
Most of the trials conducted comparing ondansetron and domperidone have been conducted among children aged below 5 or 6 years of age while no study from Pakistan has compared efficacy of these antiemetic agents among children up to 12 years of age. Read more about this study
- Who is it for?
- Ages 1 day to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Vomiting in Infants and/or Children, Acute Gastroenteritis
- What is being tested?
- Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of both genders aged below 12 years of age having 3 or more non-bilious, non-bloody vomiting episodes within 24 hours and with suggestive signs and symptoms of Acte Gastroenteritis.
Who cannot join
- Children who took any kinds of antiemetic in the last 6 hours of presentation of emergency department.
- Children having chronic liver disease, chronic kidney disease or congenital heart disease, neurological disorders, any kinds of malignancy, severe dehydration (requiring intravenous fluid replacement), severe acute malnutrition (weight-for-height below -3 standard deviation (SD) adopting WHO child growth protocols) or history known to allergy to antiemetics.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Tehsil Headquarter Hospital
Liaquatpur, Punjab Province, 64000
About this study
Official title: Comparison of Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children At a Resource Limited Setting
Most of the trials conducted comparing ondansetron and domperidone have been conducted among children aged below 5 or 6 years of age while no study from Pakistan has compared efficacy of these antiemetic agents among children up to 12 years of age. The findings of present study will give valuable evidence about the effectiveness of these antiemetic agents to prevent vomiting among children suffering with acute gastroenteritis at a resource limited setting of South Punjab, Pakistan.
Read the detailed description
to compare the efficacy of ondansetron versus domperidone for treating vomiting in acute gastroenteritis in children at a resource limited emergency setting of South Punjab, Pakistan.
- Being tested
- Ondansetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Ondansetron group received oral suspension of ondansetron as 0.15mg per body weight
| Study group | Role | What they receive |
|---|---|---|
| ondansetron group | Experimental | Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight Receives: Drug: Ondansetron |
| Domperidone group | Experimental | Children in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of vomiting
Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight while in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight. Children in both study groups were administered designated drugs in the emergency department. Children were observed in the emergency department for 6-hours and discharged if they were vomiting free. All children were asked to follow up after 24 hours for the assessment of the effectiveness of the treatment for cessation of vomiting.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Jul 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vomiting in Infants and/or ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehsil Headquarter Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Tauseef Ahmad, Tehsil Headquarter Hospital
- Investigators
- Tauseef Ahmad, MBBS, Principal investigator, Tehsil Headquarter Hospital, Liaquatpur, Pakistan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076461
- Sponsor's protocol ID
- TehsilHeadquarter
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children At a Resource Limited Setting
- ClinicalTrials.gov ID
- NCT05076461
- Acronym / sponsor ID
- TehsilHeadquarter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Tehsil Headquarter HospitalOther government
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most of the trials conducted comparing ondansetron and domperidone have been conducted among children aged below 5 or 6 years of age while no study from Pakistan has compared efficacy of these antiemetic agents among children up to 12 years of age. The findings of present study will give valuable evidence about the effectiveness of these antiemetic agents to prevent vomiting among children suffering with acute gastroenteritis at a resource limited setting of South Punjab, Pakistan.
Detailed description
to compare the efficacy of ondansetron versus domperidone for treating vomiting in acute gastroenteritis in children at a resource limited emergency setting of South Punjab, Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| ondansetron group | Experimental | Drug: OndansetronChildren in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight |
| Domperidone group | Experimental | Drug: OndansetronChildren in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight |
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children of both genders aged below 12 years of age having 3 or more non-bilious, non-bloody vomiting episodes within 24 hours and with suggestive signs and symptoms of Acte Gastroenteritis.
Key exclusion criteria (2 listed)
- Children who took any kinds of antiemetic in the last 6 hours of presentation of emergency department.
- Children having chronic liver disease, chronic kidney disease or congenital heart disease, neurological disorders, any kinds of malignancy, severe dehydration (requiring intravenous fluid replacement), severe acute malnutrition (weight-for-height below -3 standard deviation (SD) adopting WHO child growth protocols) or history known to allergy to antiemetics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronOndansetron group received oral suspension of ondansetron as 0.15mg per body weight | Drug | Domperidone group, ondansetron group |
Primary outcome
Cessation of vomiting
Time frame: 24 hours
Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight while in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight. Children in both study groups were administered designated drugs in the emergency department. Children were observed in the emergency department for 6-hours and discharged if they were vomiting free. All children were asked to follow up after 24 hours for the assessment of the effectiveness of the treatment for cessation of vomiting.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Vomiting in Infants and/or Children
Not yet recruiting
Diagnostic PCR Panel in Children With Acute Gastrointestinal Symptoms
Gastroenteritis Acute, Gastrointestinal Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tauseef Ahmad, MBBS principal investigator
Tehsil Headquarter Hospital, Liaquatpur, Pakistan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron in people with Vomiting in Infants and/or Children and Acute Gastroenteritis, run by Tehsil Headquarter Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of vomiting (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.