Conscious SedationNCT00387556
Ondansetron Reduce Vomiting Associated With Ketamine PSA
A study testing Ondansetron in people with Conscious Sedation, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department. Read more about this study
- Who is it for?
- Ages 1 year to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Dec 2006
- 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 year to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 1-21 years, ASA I or II, fracture of dislocation reduction
Who cannot join
- age < 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department
Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.
- Conditions
- Conscious Sedation
- Being tested
- Ondansetron
- Keywords
- ketamine, children, emesis
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
| Study group | Role | What they receive |
|---|---|---|
| Ketamine + Ondansetron | Experimental | ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg) Receives: Drug: Ondansetron |
| Ketamine + Placebo | Placebo comparator | ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of vomiting
The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up
Measured: Duration of ED stay and after discharge
Secondary outcomes (2)
Length of ED stay
Secondary outcome measures were length of ED stay
Measured: Duration of ED stay
Satisfaction with Sedation
patient or parent satisfaction with their sedation
Measured: Length of ED stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startDec 2002
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joe E Wathen, MD, Principal investigator, University of Colorado Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387556
- Sponsor's protocol ID
- 02-0528
- Status last verified
- May 2013
- First submitted
- 12 Oct 2006
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT00387556
- Acronym / sponsor ID
- 02-0528
- Conditions
- Conscious Sedation
- Keywords
- ketamine, children, emesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 13 Oct 2006 (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.
Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine + Ondansetron | Experimental | Drug: Ondansetronketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg) |
| Ketamine + Placebo | Placebo comparator | Drug: Ondansetronketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- age 1-21 years, ASA I or II, fracture of dislocation reduction
Key exclusion criteria (1 listed)
- age < 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.
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 |
|---|---|---|
| OndansetronAlso: Zofranondansetron (0.15 mg/kg/dose; maximum dose 4 mg) | Drug | Ketamine + Ondansetron, Ketamine + Placebo |
Primary outcome
incidence of vomiting
Time frame: Duration of ED stay and after discharge
The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up
2 secondary outcomes
Length of ED stay
Time frame: Duration of ED stay
Satisfaction with Sedation
Time frame: Length of ED stay.
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 May 2013.
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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.
Joe E Wathen, MD principal investigator
University of Colorado Health Science Center
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 Conscious Sedation, run by University of Colorado, Denver at 1 site in United States.
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 1 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 May 2013. 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 United States. 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. 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 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?
incidence of vomiting (time frame: Duration of ED stay and after discharge). 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 May 2013.