Late Onset Postoperative Nausea and Vomiting
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ClinicalTrials.gov Identifier: NCT00918190 |
Recruitment Status
:
Completed
First Posted
: June 11, 2009
Last Update Posted
: January 7, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative Nausea and Vomiting | Drug: Placebo Drug: Ondansetron, Dexamethasone Drug: Midazolam, dexamethasone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Prevention |
Official Title: | Late Onset Postoperative Nausea and Vomiting Following Strabismus Surgery in Pediatric.What Combination is Better |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Ondansetron-Dexa group
Use 2 different antiemetics
|
Drug: Ondansetron, Dexamethasone
Use of ondansetron and dexamethasone as combined antiemetics
Other Name: Zofran
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Active Comparator: Midazolam, Dexa group
use of midazolam and dexamethasone
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Drug: Midazolam, dexamethasone
use of midazolam and dexamethasone as combined antiemetic
Other Name: Midazolam
|
Placebo Comparator: Placebo
Saline will be given
|
Drug: Placebo
Saline
Other Name: saline
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- Efficacy of antiemetics combination [ Time Frame: 3 days ]

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Ages Eligible for Study: | 4 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- children undergoing elective strabismus surgery under general anesthesia
Exclusion Criteria:
- children experienced retching or vomiting
- children who have taken anti-emetic medications, antihistaminics, steroids, or psychoactive drugs within 24 hours before surgery

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918190
Saudi Arabia | |
king Khaled Eye Specialist hospital | |
Riyadh, Saudi Arabia, 11462 |
Principal Investigator: | Waleed Riad, MD, AB, SB | King Khaled Eye Specialist Hospital |
Publications:
Responsible Party: | Waleed Riad, King khaled Eye specialist hospital |
ClinicalTrials.gov Identifier: | NCT00918190 History of Changes |
Other Study ID Numbers: |
RP 0917 |
First Posted: | June 11, 2009 Key Record Dates |
Last Update Posted: | January 7, 2011 |
Last Verified: | February 2010 |
Keywords provided by King Khaled Eye Specialist Hospital:
Postoperative nausea and vomiting Pediatric Strabismus Late onset postoperative nausea and vomiting |
Additional relevant MeSH terms:
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Dexamethasone acetate Dexamethasone Ondansetron Antiemetics BB 1101 Midazolam Anti-Inflammatory Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Hypnotics and Sedatives Central Nervous System Depressants Anti-Anxiety Agents |