Post-operative VomitingXOndansetronNCT01725399
Does First Oral Intake After Emergence Predict the Incidence of Post-operative Vomiting in Children?
A study testing Apple Juice and Water in people with Post-operative Vomiting, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a medicine called ondansetron (Zofran), is in dire national shortage. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Vomiting
- What is being tested?
- Apple Juice and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2013
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Dental surgery
- Tonsillectomy and adenoidectomy
- Strabismus surgery
- Age 2-18
Who cannot join
- Patient refusal
- Parent refusal
- Allergy / contraindication to ondansetron
- Prone to vomiting
- Inpatient
- Preoperative anxiolysis with ketamine
Show all 10Show fewer
- Recovery location other than PACU
- Nil per os at baseline
- Presence of enteric tube
- Contraindication to any part of the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial: Does First Oral Intake After Emergence From Anesthesia Predict the Incidence of Post-operative Vomiting in Children?
Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a medicine called ondansetron (Zofran), is in dire national shortage. Consequently, non-pharmacological methods of prevention and treatment for post-operative nausea and vomiting have increased import. Following emergence from general anesthesia, children often request food and drink. There have been no studies to date that definitively determine the optimal first food or drink choice for these children. This study proposes to randomize children to either water or juice first intake following surgery. The investigators expect to find that children who consume glucose are less likely to vomit than those who first receive water.
- Conditions
- Post-operative Vomiting
- Being tested
- Apple Juice, Water
- Keywords
- post-operative vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple JuiceOther
WaterOther
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | Water will be given as the study subject's first oral intake after emergence from general anesthesia. Receives: Other: Water |
| Apple Juice | Experimental | Apple juice will be given as the study subject's first oral intake after emergence from general anesthesia. Receives: Other: Apple Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Vomiting
Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.
Measured: 24 hr post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative VomitingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie R Wingate, MD, Principal investigator, UNC Chapel HillPeggy P McNaull, MD, Study chair, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725399
- Sponsor's protocol ID
- 12-1792
- Acronym
- XOndansetron
- Status last verified
- Jul 2014
- First submitted
- 8 Nov 2012
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Does First Oral Intake After Emergence From Anesthesia Predict the Incidence of Post-operative Vomiting in Children?
- ClinicalTrials.gov ID
- NCT01725399
- Acronym / sponsor ID
- XOndansetron / 12-1792
- Conditions
- Post-operative Vomiting
- Keywords
- post-operative vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Nov 2012 (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.
Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a medicine called ondansetron (Zofran), is in dire national shortage. Consequently, non-pharmacological methods of prevention and treatment for post-operative nausea and vomiting have increased import. Following emergence from general anesthesia, children often request food and drink. There have been no studies to date that definitively determine the optimal first food or drink choice for these children. This study proposes to randomize children to either water or juice first intake following surgery. The investigators expect to find that children who consume glucose are less likely to vomit than those who first receive water.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Other: WaterWater will be given as the study subject's first oral intake after emergence from general anesthesia. |
| Apple Juice | Experimental | Other: Apple JuiceApple juice will be given as the study subject's first oral intake after emergence from general anesthesia. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Dental surgery
- Tonsillectomy and adenoidectomy
- Strabismus surgery
- Age 2-18
Key exclusion criteria (10 listed)
- Patient refusal
- Parent refusal
- Allergy / contraindication to ondansetron
- Prone to vomiting
- Inpatient
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 |
|---|---|---|
| Apple Juice | Other | Apple Juice |
| Water | Other | Water |
Primary outcome
Post-operative Vomiting
Time frame: 24 hr post-op
Patients will be assessed for vomiting upon entry to PACU until 24 hours post-operatively.
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 7 Aug 2014.
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Jamie R Wingate, MD principal investigator
UNC Chapel Hill
Peggy P McNaull, MD study chair
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple Juice and Water in people with Post-operative Vomiting, run by University of North Carolina, Chapel Hill 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 4 inclusion and 10 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 7 Aug 2014. 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?
Post-operative Vomiting (time frame: 24 hr post-op). 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 7 Aug 2014.