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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

June 10, 2009
January 6, 2011
June 2009
December 2010   (final data collection date for primary outcome measure)
Efficacy of antiemetics combination [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00918190 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Late Onset Postoperative Nausea and Vomiting
Late Onset Postoperative Nausea and Vomiting Following Strabismus Surgery in Pediatric.What Combination is Better

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.

The authors will study the effect of many antiemetics on the occurrence of nausea and vomiting following strabismus surgery in pediatrics.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Postoperative Nausea and Vomiting
  • Drug: Placebo
    Saline
    Other Name: saline
  • Drug: Ondansetron, Dexamethasone
    Use of ondansetron and dexamethasone as combined antiemetics
    Other Name: Zofran
  • Drug: Midazolam, dexamethasone
    use of midazolam and dexamethasone as combined antiemetic
    Other Name: Midazolam
  • Active Comparator: Ondansetron-Dexa group
    Use 2 different antiemetics
    Intervention: Drug: Ondansetron, Dexamethasone
  • Active Comparator: Midazolam, Dexa group
    use of midazolam and dexamethasone
    Intervention: Drug: Midazolam, dexamethasone
  • Placebo Comparator: Placebo
    Saline will be given
    Intervention: Drug: Placebo
Riad W, Altaf R, Abdulla A, Oudan H. Effect of midazolam, dexamethasone and their combination on the prevention of nausea and vomiting following strabismus repair in children. Eur J Anaesthesiol. 2007 Aug;24(8):697-701. Epub 2007 Apr 17. Erratum in: Eur J Anaesthesiol. 2008 Jan;25(1):88.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
4 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
NCT00918190
RP 0917
Yes
Waleed Riad, King khaled Eye specialist hospital
King Khaled Eye Specialist Hospital
Not Provided
Principal Investigator: Waleed Riad, MD, AB, SB King Khaled Eye Specialist Hospital
King Khaled Eye Specialist Hospital
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP