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Late Onset Postoperative Nausea and Vomiting
This study has been completed.
Sponsor:
King Khaled Eye Specialist Hospital
Information provided by:
King Khaled Eye Specialist Hospital
ClinicalTrials.gov Identifier:
NCT00918190
First received: June 10, 2009
Last updated: January 6, 2011
Last verified: February 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
| Postoperative Nausea and Vomiting | Drug: Placebo Drug: Ondansetron, Dexamethasone Drug: Midazolam, dexamethasone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider) Primary Purpose: Prevention |
| Official Title: | Late Onset Postoperative Nausea and Vomiting Following Strabismus Surgery in Pediatric.What Combination is Better |
Resource links provided by NLM:
Further study details as provided by King Khaled Eye Specialist Hospital:
Primary Outcome Measures:
- Efficacy of antiemetics combination [ Time Frame: 3 days ]
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ondansetron-Dexa group
Use 2 different antiemetics
|
Drug: Ondansetron, Dexamethasone
Use of ondansetron and dexamethasone as combined antiemetics
Other Name: Zofran
|
|
Active Comparator: Midazolam, Dexa group
use of midazolam and dexamethasone
|
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
|
Detailed Description:
The authors will study the effect of many antiemetics on the occurrence of nausea and vomiting following strabismus surgery in pediatrics.
Eligibility| Ages Eligible for Study: | 4 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00918190
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918190
Locations
| Saudi Arabia | |
| king Khaled Eye Specialist hospital | |
| Riyadh, Saudi Arabia, 11462 | |
Sponsors and Collaborators
King Khaled Eye Specialist Hospital
Investigators
| Principal Investigator: | Waleed Riad, MD, AB, SB | King Khaled Eye Specialist Hospital |
More Information
Publications:
| Responsible Party: | Waleed Riad, King khaled Eye specialist hospital |
| ClinicalTrials.gov Identifier: | NCT00918190 History of Changes |
| Other Study ID Numbers: |
RP 0917 |
| Study First Received: | June 10, 2009 |
| Last Updated: | January 6, 2011 |
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 Dexamethasone 21-phosphate 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 |
ClinicalTrials.gov processed this record on June 23, 2017