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Late Onset Postoperative Nausea and Vomiting

This study has been completed.
Sponsor:
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
History of Changes
  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
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:

U.S. FDA Resources

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
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
Genders Eligible for Study:   Both
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
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
Health Authority: Saudi Arabia: Ministry of Health

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
Antiemetics
Dexamethasone
Ondansetron
Dexamethasone acetate
Dexamethasone 21-phosphate
Midazolam
BB 1101
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013