NCT05124067

Brief Summary

this study will aim to evaluate the effects of dexmedetomidine, dexamethasone and Ondansetron on the prevention of postoperative nausea and vomiting in children undergoing dental rehabilitation surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

November 5, 2021

Last Update Submit

April 3, 2022

Conditions

Postoperative Nausea and VomitingPost Operative PainEmergence Delirium

Keywords

dexmedetomidinenausea and vomiting

Outcome Measures

Primary Outcomes (1)

  • Number of participants who will develop postoperative nausea and vomiting and rate of development

    Postoperative vomiting will be recorded by a nurse who will be blinded to study conditions. It will be treated if vomiting occurred more than twice in 2 minutes with granisetron (0.1mg/kg and repeated if necessary but not in less than 12 hours).

    24 hours

Secondary Outcomes (2)

  • Postoperative pain

    24 hours

  • Emergence delirium

    15 minutes

Other Outcomes (2)

  • Total granisetron dose given

    24 hours

  • Number of participants with the following side effects

    24 hours

Study Arms (4)

Group A (DEXA)

EXPERIMENTAL

patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg)

Drug: Dexamethasone

Group B (ONDAN)

EXPERIMENTAL

patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg)

Drug: Ondansetron

Group C (DEXMED)

EXPERIMENTAL

Patients will receive dexmedetomidine (0.3 μg/kg)

Drug: Dexmedetomidine

Group D (CONTROL)

PLACEBO COMPARATOR

patients will receive normal saline

Drug: normal Saline

Interventions

DexamethasoneDRUG

patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg)

Also known as: Dexamethasone Group
Group A (DEXA)
OndansetronDRUG

patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg)

Also known as: Ondansetron Group
Group B (ONDAN)
DexmedetomidineDRUG

Patients will receive dexmedetomidine (0.3 μg/kg)

Also known as: Dexmedetomidine Group
Group C (DEXMED)
normal SalineDRUG

patients will receive normal saline.

Also known as: Control Group
Group D (CONTROL)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients 6-12 years.
  • Pediatric patients (ASA physical status I, II).
  • Scheduled for dental rehabilitation surgery

You may not qualify if:

  • Parental refusal
  • Allergy or contraindication to studied medication or anaesthetic agents.
  • Children with known gastroesophageal reflux disease.
  • Intake of antiemetic medication within 24 hours before surgery.
  • Past history or family history of previous postoperative nausea and vomiting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharurah Armed Forces Hospital

Sharurah, Najran Region, 00000, Saudi Arabia

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingPain, PostoperativeEmergence DeliriumNauseaVomiting

Interventions

DexamethasoneOndansetronDexmedetomidineSaline SolutionControl Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and SymptomsPainNeurologic ManifestationsDeliriumConfusionNeurobehavioral ManifestationsNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • AHMED A SHAMA, MD

    LECTURER OF ANESTHESIA AND SURGICAL ICU, TANTA UNIVERSITY, FACULTY OF MEDICINE

    PRINCIPAL INVESTIGATOR

  • SHERIF K ARAFA, MD

    Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINE

    STUDY CHAIR

  • AMIR A EL-SAYED, MD

    Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINE

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER OF ANESTHESIA AND SURGICAL ICU

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 17, 2021

Study Start

October 27, 2021

Primary Completion

January 30, 2022

Study Completion

March 12, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)