Late Onset Postoperative Nausea and Vomiting

This study has been completed.
Information provided by:
King Khaled Eye Specialist Hospital Identifier:
First received: June 10, 2009
Last updated: January 6, 2011
Last verified: February 2010
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]

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
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.

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00918190

Saudi Arabia
king Khaled Eye Specialist hospital
Riyadh, Saudi Arabia, 11462
Sponsors and Collaborators
King Khaled Eye Specialist Hospital
Principal Investigator: Waleed Riad, MD, AB, SB King Khaled Eye Specialist Hospital
  More Information

Responsible Party: Waleed Riad, King khaled Eye specialist hospital Identifier: NCT00918190     History of Changes
Other Study ID Numbers: RP 0917 
Study First Received: June 10, 2009
Last Updated: January 6, 2011
Health Authority: Saudi Arabia: Ministry of Health

Keywords provided by King Khaled Eye Specialist Hospital:
Postoperative nausea and vomiting
Late onset postoperative nausea and vomiting

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Adjuvants, Anesthesia
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antipsychotic Agents
Autonomic Agents
Central Nervous System Depressants
Dermatologic Agents
Enzyme Inhibitors
GABA Agents
GABA Modulators processed this record on May 26, 2016