Postoperative Nausea and VomitingNCT00918190
Late Onset Postoperative Nausea and Vomiting
A study testing Ondansetron, Dexamethasone and Midazolam, dexamethasone in people with Postoperative Nausea and Vomiting, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
Trial summary
The purpose of this trial is to study the effects of different combinations of antiemetics on the incidence of late onset postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Ondansetron, Dexamethasone and Midazolam, dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jun 2009to Dec 2010
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children undergoing elective strabismus surgery under general anesthesia
Who cannot join
- children experienced retching or vomiting
- children who have taken anti-emetic medications, antihistaminics, steroids, or psychoactive drugs within 24 hours before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Late Onset Postoperative Nausea and Vomiting Following Strabismus Surgery in Pediatric.What Combination is Better
The purpose of this trial is to study the effects of different combinations of antiemetics on the incidence of late onset postoperative nausea and vomiting.
Read the detailed description
The authors will study the effect of many antiemetics on the occurrence of nausea and vomiting following strabismus surgery in pediatrics.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Placebo, Ondansetron, Dexamethasone, Midazolam, dexamethasone
- Keywords
- Postoperative nausea and vomiting, Pediatric, Strabismus, Late onset postoperative nausea and vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting, Strabismus, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called saline
Saline
Ondansetron, DexamethasoneDrug
Also called Zofran
Use of ondansetron and dexamethasone as combined antiemetics
Midazolam, dexamethasoneDrug
Also called Midazolam
use of midazolam and dexamethasone as combined antiemetic
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron-Dexa group | Active comparator | Use 2 different antiemetics Receives: Drug: Ondansetron, Dexamethasone |
| Midazolam, Dexa group | Active comparator | use of midazolam and dexamethasone Receives: Drug: Midazolam, dexamethasone |
| Placebo | Placebo comparator | Saline will be given Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of antiemetics combination
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Khaled Eye Specialist Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Waleed Riad, MD, AB, SB, Principal investigator, King Khaled Eye Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918190
- Sponsor's protocol ID
- RP 0917
- Status last verified
- Oct 2021
- First submitted
- 10 Jun 2009
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Riad W, Altaf R, Abdulla A, Oudan H. Effect of midazolam, dexamethasone and their combination on the prevention of nausea and vomiting following strabismus repair in children. Eur J Anaesthesiol. 2007 Aug;24(8):697-701. doi: 10.1017/S0265021507000166. Epub 2007 Apr 17.
PubMed 17437654
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Onset Postoperative Nausea and Vomiting Following Strabismus Surgery in Pediatric.What Combination is Better
- ClinicalTrials.gov ID
- NCT00918190
- Acronym / sponsor ID
- RP 0917
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative nausea and vomiting, Pediatric, Strabismus, Late onset postoperative nausea and vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- King Khaled Eye Specialist HospitalOther government
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Jun 2009 (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 trial is to study the effects of different combinations of antiemetics on the incidence of late onset postoperative nausea and vomiting.
Detailed description
The authors will study the effect of many antiemetics on the occurrence of nausea and vomiting following strabismus surgery in pediatrics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ondansetron-Dexa group | Active comparator | Drug: Ondansetron, DexamethasoneUse 2 different antiemetics |
| Midazolam, Dexa group | Active comparator | Drug: Midazolam, dexamethasoneuse of midazolam and dexamethasone |
| Placebo | Placebo comparator | Drug: PlaceboSaline will be given |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children undergoing elective strabismus surgery under general anesthesia
Key exclusion criteria (2 listed)
- children experienced retching or vomiting
- children who have taken anti-emetic medications, antihistaminics, steroids, or psychoactive drugs within 24 hours before surgery
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 |
|---|---|---|
| PlaceboAlso: salineSaline | Drug | Placebo |
| Ondansetron, DexamethasoneAlso: ZofranUse of ondansetron and dexamethasone as combined antiemetics | Drug | Ondansetron-Dexa group |
| Midazolam, dexamethasoneAlso: Midazolamuse of midazolam and dexamethasone as combined antiemetic | Drug | Midazolam, Dexa group |
Primary outcome
Efficacy of antiemetics combination
Time frame: 3 days
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 19 Oct 2021.
- Background: PubMed 17437654Riad W, Altaf R, Abdulla A, Oudan H. Effect of midazolam, dexamethasone and their combination on the prevention of nausea and vomiting following strabismus repair in children. Eur J Anaesthesiol. 2007 Aug;24(8):697-701. doi: 10.1017/S0265021507000166. Epub 2007 Apr 17.
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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.
Waleed Riad, MD, AB, SB principal investigator
King Khaled Eye Specialist 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, Dexamethasone and Midazolam, dexamethasone in people with Postoperative Nausea and Vomiting, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
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 19 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 Saudi Arabia. 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?
Efficacy of antiemetics combination (time frame: 3 days). 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 NCT00918190, which also lists 1 linked publication.
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 19 Oct 2021.