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Late Onset Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status

Completed

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Placebo

Ondansetron, Dexamethasone

Midazolam, dexamethasone

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Postoperative nausea and vomiting, Pediatric, Strabismus, Late onset postoperative nausea and vomiting

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

king Khaled Eye Specialist hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ondansetron-Dexa group

Midazolam, Dexa group

Placebo

Arm Description

Use 2 different antiemetics

use of midazolam and dexamethasone

Saline will be given

Outcomes

Primary Outcome Measures

Efficacy of antiemetics combination

Secondary Outcome Measures

Full Information

NCT ID

NCT00918190

First Posted

June 10, 2009

Last Updated

October 10, 2021

Sponsor

King Khaled Eye Specialist Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00918190

Brief Title

Late Onset Postoperative Nausea and Vomiting

Official Title

Late Onset Postoperative Nausea and Vomiting Following Strabismus Surgery in Pediatric.What Combination is Better

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

King Khaled Eye Specialist Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

Keywords

Postoperative nausea and vomiting, Pediatric, Strabismus, Late onset postoperative nausea and vomiting

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ondansetron-Dexa group

Arm Type

Active Comparator

Arm Description

Use 2 different antiemetics

Arm Title

Midazolam, Dexa group

Arm Type

Active Comparator

Arm Description

use of midazolam and dexamethasone

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Saline will be given

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

saline

Intervention Description

Saline

Intervention Type

Drug

Intervention Name(s)

Ondansetron, Dexamethasone

Other Intervention Name(s)

Zofran

Intervention Description

Use of ondansetron and dexamethasone as combined antiemetics

Intervention Type

Drug

Intervention Name(s)

Midazolam, dexamethasone

Other Intervention Name(s)

Midazolam

Intervention Description

use of midazolam and dexamethasone as combined antiemetic

Primary Outcome Measure Information:

Title

Efficacy of antiemetics combination

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Waleed Riad, MD, AB, SB

Organizational Affiliation

King Khaled Eye Specialist Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

king Khaled Eye Specialist hospital

City

Riyadh

ZIP/Postal Code

11462

Country

Saudi Arabia

12. IPD Sharing Statement

Citations:

PubMed Identifier

17437654

Citation

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. doi: 10.1017/S0265021507000166. Epub 2007 Apr 17. Erratum In: Eur J Anaesthesiol. 2008 Jan;25(1):88.

Results Reference

background

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Late Onset Postoperative Nausea and Vomiting

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