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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
Sponsor:
Information provided by:
King Khaled Eye Specialist Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Placebo Drug: Ondansetron, Dexamethasone Drug: Midazolam, dexamethasone Not Applicable

Detailed Description:
The authors will study the effect of many antiemetics on the occurrence of nausea and vomiting following strabismus surgery in pediatrics.

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
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



Primary Outcome Measures :
  1. 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
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

Information from the National Library of Medicine

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


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

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