Sedation and AnalgesiaNCT01477242
The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department
A study testing Ondansetron in people with Sedation and Analgesia and Side Effect of Drug, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this evaluation, the investigators will perform a multi-center, double-blind, placebo-controled, randomized study. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Sedation and Analgesia, Side Effect of Drug
- What is being tested?
- Ondansetron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to May 2012
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- children under 18 years of age
- children who are planned to admit ketamine intramuscular injection
- children with ASA classification class I or II
Who cannot join
- don't want to enroll to study
- children with condition of contraindication of ketamine (IICP, IIOP, psychosis, brain tumor, thyroid disease, porphyria)
- children with condition of contraindication of ondansetron (hypersensitivity to 5-HT3 antagonist, Long QT syndrome, severe liver failure, obstructive ileus)
- children under 3 months of age
- children whose weight are over 30 kg
- children managed by other drug with ketamine
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110744
Do Kyun Kim, M.D., 82-2-2072-0238
Do Kyun Kim, M.D.
About this study
Official title: The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children
The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this evaluation, the investigators will perform a multi-center, double-blind, placebo-controled, randomized study. The investigators assumption is that oral ondansetron prior to intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.
Read the detailed description
Methods
- a multi-center, double-blind, placebo-controled, randomized study ( 4 tertiary hospital ED)
- survey for the occurrence of vomiting at ED and after discharge
Primary outcome
- the number of vomiting at ED and at home
Secondary outcome
- parent's satisfaction and ED length of stay
- Conditions
- Sedation and Analgesia, Side Effect of Drug
- Being tested
- Ondansetron
- Keywords
- vomiting, anti-emetics, ketamine, sedation
- Medical subject headings
- Agnosia, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran zydis, vomiset
2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | Ondansetron use group Receives: Drug: Ondansetron |
| Placebo | Placebo comparator | Placebo group Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
vomiting at ED stay and 12 hours after discharge
Measured: the participants will be followed for the duration of ED stay (upto 24hr) and 12hours after discharge
Secondary outcomes (2)
parent's satisfaction
Measured: satisfaction will be surveyed within 48hours after discharge
length of emergency department stay
Measured: length of stay will be calculated upto 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation and AnalgesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Myongji Hospital
- Responsible party
- Principal investigator, Do Kyun Kim, Seoul National University Hospital
- Investigators
- Do Kyun Kim, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477242
- Sponsor's protocol ID
- H-1105-114-364
- Status last verified
- Jan 2012
- First submitted
- 23 Oct 2011
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children
- ClinicalTrials.gov ID
- NCT01477242
- Acronym / sponsor ID
- H-1105-114-364
- Conditions
- Sedation and Analgesia, Side Effect of Drug
- Keywords
- vomiting, anti-emetics, ketamine, sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center, Myongji Hospital
- Study start
- Nov 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 22 Nov 2011 (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.
The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this evaluation, the investigators will perform a multi-center, double-blind, placebo-controled, randomized study. The investigators assumption is that oral ondansetron prior to intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.
Detailed description
Methods
- a multi-center, double-blind, placebo-controled, randomized study ( 4 tertiary hospital ED)
- survey for the occurrence of vomiting at ED and after discharge
Primary outcome
- the number of vomiting at ED and at home
Secondary outcome
- parent's satisfaction and ED length of stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Experimental | Drug: OndansetronOndansetron use group |
| Placebo | Placebo comparator | Drug: OndansetronPlacebo group |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- children under 18 years of age
- children who are planned to admit ketamine intramuscular injection
- children with ASA classification class I or II
Key exclusion criteria (6 listed)
- don't want to enroll to study
- children with condition of contraindication of ketamine (IICP, IIOP, psychosis, brain tumor, thyroid disease, porphyria)
- children with condition of contraindication of ondansetron (hypersensitivity to 5-HT3 antagonist, Long QT syndrome, severe liver failure, obstructive ileus)
- children under 3 months of age
- children whose weight are over 30 kg
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: Zofran zydis, vomiset2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg | Drug | Ondansetron, Placebo |
Primary outcome
vomiting at ED stay and 12 hours after discharge
Time frame: the participants will be followed for the duration of ED stay (upto 24hr) and 12hours after discharge
2 secondary outcomes
parent's satisfaction
Time frame: satisfaction will be surveyed within 48hours after discharge
length of emergency department stay
Time frame: length of stay will be calculated upto 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
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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.
Do Kyun Kim, M.D. principal investigator
Seoul National University Hospital
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 Sedation and Analgesia and Side Effect of Drug, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Jan 2012. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Do Kyun Kim, M.D. (82-2-2072-0238, birdbeak@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vomiting at ED stay and 12 hours after discharge (time frame: the participants will be followed for the duration of ED stay (upto 24hr) and 12hours 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 20 Jan 2012.