Late Onset Postoperative Nausea and Vomiting

NCT ID: NCT00918190

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-31

Brief Summary

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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

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

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Ondansetron-Dexa group

Use 2 different antiemetics

Group Type ACTIVE_COMPARATOR

Ondansetron, Dexamethasone

Intervention Type DRUG

Use of ondansetron and dexamethasone as combined antiemetics

Midazolam, Dexa group

use of midazolam and dexamethasone

Group Type ACTIVE_COMPARATOR

Midazolam, dexamethasone

Intervention Type DRUG

use of midazolam and dexamethasone as combined antiemetic

Placebo

Saline will be given

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline

Interventions

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Placebo

Saline

Intervention Type DRUG

Ondansetron, Dexamethasone

Use of ondansetron and dexamethasone as combined antiemetics

Intervention Type DRUG

Midazolam, dexamethasone

use of midazolam and dexamethasone as combined antiemetic

Intervention Type DRUG

Other Intervention Names

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saline Zofran Midazolam

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Khaled Eye Specialist Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Waleed Riad, MD, AB, SB

Role: PRINCIPAL_INVESTIGATOR

King Khaled Eye Specialist Hospital

Locations

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king Khaled Eye Specialist hospital

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type BACKGROUND
PMID: 17437654 (View on PubMed)

Other Identifiers

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RP 0917

Identifier Type: -

Identifier Source: org_study_id