NCT00918190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

1.5 years

First QC Date

June 10, 2009

Last Update Submit

October 10, 2021

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative nausea and vomitingPediatricStrabismusLate onset postoperative nausea and vomiting

Outcome Measures

Primary Outcomes (1)

  • Efficacy of antiemetics combination

    3 days

Study Arms (3)

Ondansetron-Dexa group

ACTIVE COMPARATOR

Use 2 different antiemetics

Drug: Ondansetron, Dexamethasone

Midazolam, Dexa group

ACTIVE COMPARATOR

use of midazolam and dexamethasone

Drug: Midazolam, dexamethasone

Placebo

PLACEBO COMPARATOR

Saline will be given

Drug: Placebo

Interventions

PlaceboDRUG

Saline

Also known as: saline
Placebo
Ondansetron, DexamethasoneDRUG

Use of ondansetron and dexamethasone as combined antiemetics

Also known as: Zofran
Ondansetron-Dexa group
Midazolam, dexamethasoneDRUG

use of midazolam and dexamethasone as combined antiemetic

Also known as: Midazolam
Midazolam, Dexa group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children undergoing elective strabismus surgery under general anesthesia

You may not qualify if:

  • children experienced retching or vomiting
  • children who have taken anti-emetic medications, antihistaminics, steroids, or psychoactive drugs within 24 hours before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

king Khaled Eye Specialist hospital

Riyadh, 11462, Saudi Arabia

Location

Related Publications (1)

  • 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.

    PMID: 17437654BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and VomitingStrabismusVomiting

Interventions

Sodium ChlorideOndansetronDexamethasoneMidazolam

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzodiazepinesBenzazepines

Study Officials

  • Waleed Riad, MD, AB, SB

    King Khaled Eye Specialist Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 11, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

SA(1)