NCT06879496

Brief Summary

The aim of this study is to compare between oral dexmedetomidine, Ketamine or midazolam for premedication in children undergoing inguinal hernia surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2025

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

March 10, 2025

Last Update Submit

January 12, 2026

Conditions

PediatricAnesthesia

Keywords

KetaminMidazolamDexmedetomidineOralPediatric

Outcome Measures

Primary Outcomes (1)

  • Primary outcome

    five-point sedation score

    on arrival in the operating room 30 min after end of study drug administration.

Secondary Outcomes (1)

  • Secondary outcome

    Till 1 hour after operation

Study Arms (3)

Group K

ACTIVE COMPARATOR

Patients will receive orally ketamin 6 mg/kg.

Drug: Oral ketamin

Group D

ACTIVE COMPARATOR

Patients will receive orally dexmedetomidine 4 mcg kg -1

Drug: Oral dexmedetomidine

Group M

ACTIVE COMPARATOR

Patients will receive orally midazolam 0.5 mg kg -1.

Drug: Oral Midazolam

Interventions

Oral ketaminDRUG

Patients will be received oral ketamine before operation

Group K
Oral MidazolamDRUG

Patients will be received oral Midazolam

Group M
Oral dexmedetomidineDRUG

Patients will be received oral dexmedetomidine

Group D

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 3-7 years.
  • Both sexes.
  • American society of anesthesiologists (ASA) physical status (I-II).

You may not qualify if:

  • Parents refusal.
  • Patients with known allergy to the study drugs.
  • Significant organ dysfunction.
  • Cardiac dysrhythmia.
  • Use of psychotropic medication, and mental retardation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Zakarea Wfa

Tanta, Tanta, 6620010, Egypt

Location

MeSH Terms

Interventions

MidazolamDexmedetomidine

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 17, 2025

Study Start

March 10, 2025

Primary Completion

September 10, 2025

Study Completion

September 10, 2025

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

EG(1)