DehydrationNCT00691275
Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
A study testing Ondansetron and Saline in people with Dehydration and Gastroenteritis, run by Children's Hospitals and Clinics of Minnesota.
Trial summary
Dehydration due to vomiting is a common complication of acute gastroenteritis in children. Persistent vomiting following rehydration is a problem in outpatient management using oral rehydration therapy. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Dehydration, Gastroenteritis
- What is being tested?
- Ondansetron and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Sep 2009
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 months - 5 years
- Clinical diagnosis of acute gastroenteritis
- Mild or moderate dehydration as determined by validated clinical scale
- Clinical assessment to begin IV fluids
- Vomiting ≥ 2 episodes in past 4 hours
Who cannot join
- Severe dehydration
- History of significant gastrointestinal, metabolic, renal or cardiac disorder
- Ondansetron allergy
- Non-English language proficient parent/guardian
- Parent/guardian has no telephone
About this study
Official title: Ondansetron vs. Placebo in the Management of Children With Dehydration Due to Acute Gastroenteritis
Dehydration due to vomiting is a common complication of acute gastroenteritis in children. Persistent vomiting following rehydration is a problem in outpatient management using oral rehydration therapy.
Four previous studies have examined the role of the medication, ondansetron, in treating nausea and vomiting in children with gastroenteritis and have suggested that it may be beneficial [1-4]. A previous study has also shown that the administration of intravenous fluid alone to children with dehydration due to gastroenteritis helps resolve nausea and vomiting in the majority of patients [5]. None of the previous studies compared the efficacy of intravenous ondansetron with that of intravenous fluid alone in the prevention of vomiting . In addition, the previous studies were limited by poorly defined inclusion criteria and outcome measures.
Read more
The proposed study seeks to more clearly define the role of intravenous ondansetron in the management of children suffering dehydration due to acute gastroenteritis. If ondansetron further reduces the incidence of vomiting compared with intravenous fluid alone, more children with dehydration due to acute gastroenteritis may be successfully discharged to home from the emergency department instead of admitted to the hospital. If it does not, the widespread use of ondansetron for such patients could be discouraged and money could be saved.
Hypothesis:
Patients receiving ondansetron in addition to intravenous fluids for the treatment of dehydration due to vomiting caused by gastroenteritis will not have a significant reduction in the occurrence of persistent vomiting as compared to those who receive only intravenous fluids.
- Conditions
- Dehydration, Gastroenteritis
- Being tested
- Ondansetron, Saline
- Keywords
- dehydration, acute gastroenteritis, ondansetron, rehydration
- Medical subject headings
- Dehydration, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Saline Receives: Drug: Saline |
| 1 | Active comparator | Zofran Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Received further IV fluids
Measured: 2-7 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Sam Reid, MD, Principal investigator, Children's Hospitals and Clinics of MinnesotaHenry Ortega, MD, Principal investigator, Children's Hospitals and Clinics of MinnesotaJeffrey Louie, MD, Principal investigator, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691275
- Sponsor's protocol ID
- 0801-012
- Status last verified
- Jul 2015
- First submitted
- 3 Jun 2008
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705. doi: 10.1056/NEJMoa055119.
PubMed 16625009Reeves JJ, Shannon MW, Fleisher GR. Ondansetron decreases vomiting associated with acute gastroenteritis: a randomized, controlled trial. Pediatrics. 2002 Apr;109(4):e62. doi: 10.1542/peds.109.4.e62.
PubMed 11927735Ramsook C, Sahagun-Carreon I, Kozinetz CA, Moro-Sutherland D. A randomized clinical trial comparing oral ondansetron with placebo in children with vomiting from acute gastroenteritis. Ann Emerg Med. 2002 Apr;39(4):397-403. doi: 10.1067/mem.2002.122706.
PubMed 11919526Stork CM, Brown KM, Reilly TH, Secreti L, Brown LH. Emergency department treatment of viral gastritis using intravenous ondansetron or dexamethasone in children. Acad Emerg Med. 2006 Oct;13(10):1027-33. doi: 10.1197/j.aem.2006.05.018. Epub 2006 Aug 10.
PubMed 16902049Reid SR, Bonadio WA. Outpatient rapid intravenous rehydration to correct dehydration and resolve vomiting in children with acute gastroenteritis. Ann Emerg Med. 1996 Sep;28(3):318-23. doi: 10.1016/s0196-0644(96)70032-x.
PubMed 8780476
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron vs. Placebo in the Management of Children With Dehydration Due to Acute Gastroenteritis
- ClinicalTrials.gov ID
- NCT00691275
- Acronym / sponsor ID
- 0801-012
- Conditions
- Dehydration, Gastroenteritis
- Keywords
- dehydration, acute gastroenteritis, ondansetron, rehydration
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 5 Jun 2008 (estimated)
- 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.
Dehydration due to vomiting is a common complication of acute gastroenteritis in children. Persistent vomiting following rehydration is a problem in outpatient management using oral rehydration therapy.
Four previous studies have examined the role of the medication, ondansetron, in treating nausea and vomiting in children with gastroenteritis and have suggested that it may be beneficial [1-4]. A previous study has also shown that the administration of intravenous fluid alone to children with dehydration due to gastroenteritis helps resolve nausea and vomiting in the majority of patients [5]. None of the previous studies compared the efficacy of intravenous ondansetron with that of intravenous fluid alone in the prevention of vomiting . In addition, the previous studies were limited by poorly defined inclusion criteria and outcome measures.
The proposed study seeks to more clearly define the role of intravenous ondansetron in the management of children suffering dehydration due to acute gastroenteritis. If ondansetron further reduces the incidence of vomiting compared with intravenous fluid alone, more children with dehydration due to acute gastroenteritis may be successfully discharged to home from the emergency department instead of admitted to the hospital. If it does not, the widespread use of ondansetron for such patients could be discouraged and money could be saved.
Hypothesis:
Patients receiving ondansetron in addition to intravenous fluids for the treatment of dehydration due to vomiting caused by gastroenteritis will not have a significant reduction in the occurrence of persistent vomiting as compared to those who receive only intravenous fluids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: SalineSaline |
| 1 | Active comparator | Drug: OndansetronZofran |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6 months - 5 years
- Clinical diagnosis of acute gastroenteritis
- Mild or moderate dehydration as determined by validated clinical scale
- Clinical assessment to begin IV fluids
- Vomiting ≥ 2 episodes in past 4 hours
Key exclusion criteria (5 listed)
- Severe dehydration
- History of significant gastrointestinal, metabolic, renal or cardiac disorder
- Ondansetron allergy
- Non-English language proficient parent/guardian
- Parent/guardian has no telephone
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 |
|---|---|---|
| Ondansetron | Drug | 1 |
| Saline | Drug | 2 |
Primary outcome
Received further IV fluids
Time frame: 2-7 days post discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Background: PubMed 16625009Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705. doi: 10.1056/NEJMoa055119.
- Background: PubMed 11927735Reeves JJ, Shannon MW, Fleisher GR. Ondansetron decreases vomiting associated with acute gastroenteritis: a randomized, controlled trial. Pediatrics. 2002 Apr;109(4):e62. doi: 10.1542/peds.109.4.e62.
- Background: PubMed 11919526Ramsook C, Sahagun-Carreon I, Kozinetz CA, Moro-Sutherland D. A randomized clinical trial comparing oral ondansetron with placebo in children with vomiting from acute gastroenteritis. Ann Emerg Med. 2002 Apr;39(4):397-403. doi: 10.1067/mem.2002.122706.
- Background: PubMed 16902049Stork CM, Brown KM, Reilly TH, Secreti L, Brown LH. Emergency department treatment of viral gastritis using intravenous ondansetron or dexamethasone in children. Acad Emerg Med. 2006 Oct;13(10):1027-33. doi: 10.1197/j.aem.2006.05.018. Epub 2006 Aug 10.
- Background: PubMed 8780476Reid SR, Bonadio WA. Outpatient rapid intravenous rehydration to correct dehydration and resolve vomiting in children with acute gastroenteritis. Ann Emerg Med. 1996 Sep;28(3):318-23. doi: 10.1016/s0196-0644(96)70032-x.
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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.
Sam Reid, MD principal investigator
Children's Hospitals and Clinics of Minnesota
Henry Ortega, MD principal investigator
Children's Hospitals and Clinics of Minnesota
Jeffrey Louie, MD principal investigator
Children's Hospitals and Clinics of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron and Saline in people with Dehydration and Gastroenteritis, run by Children's Hospitals and Clinics of Minnesota.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Received further IV fluids (time frame: 2-7 days post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00691275, which also lists 5 linked publications.
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 14 Jul 2015.