NCT05837000

Brief Summary

Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

April 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.4 years

First QC Date

April 19, 2023

Last Update Submit

June 10, 2023

Conditions

Preemptive AnalgesiaDexmedetomidineKetamineMagnesium SulphateHypospadiasPediatrics

Outcome Measures

Primary Outcomes (1)

  • First time of rescue analgesia requirement

    If the FLACC score is ≥ 4, pethidine 1 mg/kg. The first time to require analgesia will be calculated (the time from caudal block to the first time to pethidine injection).

    24 hours postoperatively

Secondary Outcomes (3)

  • Total consumption of rescue analgesia

    24 hours postoperatively

  • Pain score

    24 hours postoperatively

  • The incidence of adverse effects

    24 hours postoperatively

Study Arms (3)

Dexmedetomidine

EXPERIMENTAL

0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally

Drug: Dexmedetomidine

Ketamine

EXPERIMENTAL

0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally

Drug: Ketamine

Magnesium sulphate

EXPERIMENTAL

0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.

Drug: Magnesium sulphate

Interventions

DexmedetomidineDRUG

Patient will receive 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally

Dexmedetomidine
KetamineDRUG

Patient will receive 0.5ml/kg bupivacaine 0.25% + 0.5mg/kg ketamine caudally

Ketamine
Magnesium sulphateDRUG

Patient will receive 0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.

Magnesium sulphate

Eligibility Criteria

Age1 Year - 7 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmales
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 1-7 years
  • American Society of Anesthesiologists (ASA) classification I and II, undergoing hypospadias repair.

You may not qualify if:

  • Developmental delay
  • Psychological or neurological disorders
  • Difficult airway
  • Hyperactive airway disease or children in whom caudal block was contraindicated (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karelsheikh University Hospital

Kafr ash Shaykh, Karelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

Hypospadias

Interventions

DexmedetomidineKetamineMagnesium Sulfate

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Kafrelsheikh University

    Research ethics committee - Kafrelsheikh University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamal MD Hendawy Shams, MD

CONTACT

00201095927971gamal.shams@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 1, 2023

Study Start

May 15, 2023

Primary Completion

October 25, 2024

Study Completion

October 25, 2024

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

The data will be available upon Reasonable request from the corresponding author for one year after study completion

Shared Documents
STUDY PROTOCOL
Time Frame
The data will be available for one year after study completion
Access Criteria
The data will be available upon Reasonable request from the corresponding author.

Available IPD Datasets

Study Protocol (MKSU 51- 2 _ 16)Access

Locations

EG(1)