Late Onset Postoperative Nausea and Vomiting - Full Text View

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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate Midazolam maleate Midazolam hydrochloride Ondansetron hydrochloride Ondansetron

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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.


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 Postoperative Nausea and Vomiting Vomiting Pathologic Processes Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive BB 1101 Dexamethasone Dexamethasone 21-phosphate Dexamethasone acetate Midazolam Ondansetron Adjuvants, Anesthesia Anesthetics	Anesthetics, General Anesthetics, Intravenous Anti-Anxiety Agents Anti-Inflammatory Agents Antiemetics Antineoplastic Agents Antineoplastic Agents, Hormonal Antipruritics Antipsychotic Agents Autonomic Agents Central Nervous System Agents Central Nervous System Depressants Dermatologic Agents Enzyme Inhibitors GABA Agents

ClinicalTrials.gov processed this record on March 02, 2015