Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair

Sponsor

Kafrelsheikh University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05837000

Collaborator

(none)

Enrollment

Location

Arms

17.4

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preemptive Analgesia Dexmedetomidine Ketamine Magnesium Sulphate Hypospadias Pediatrics	Drug: Dexmedetomidine Drug: Ketamine Drug: Magnesium sulphate	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Role of Adding Dexmedetomidine, Ketamine and Magnesium Sulphate to Caudal Block as Preemptive Analgesia in Hypospadias Repair in Pediatrics: a Randomized Double-blinded Trial

Anticipated Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

Oct 25, 2024

Anticipated Study Completion Date :

Oct 25, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally	Drug: Dexmedetomidine Patient will receive 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
Experimental: Ketamine 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally	Drug: Ketamine Patient will receive 0.5ml/kg bupivacaine 0.25% + 0.5mg/kg ketamine caudally
Experimental: Magnesium sulphate 0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.	Drug: Magnesium sulphate Patient will receive 0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.

Arm

Intervention/Treatment

Experimental: Dexmedetomidine

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

Drug: Dexmedetomidine

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

Experimental: Ketamine

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

Drug: Ketamine

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

Experimental: Magnesium sulphate

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

Drug: Magnesium sulphate

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

Outcome Measures

Primary Outcome Measures

First time of rescue analgesia requirement [24 hours postoperatively]
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).

Secondary Outcome Measures

Total consumption of rescue analgesia [24 hours postoperatively]
If the FLACC score is ≥ 4, pethidine 1 mg/kg. The total pethidine consumption of patients require analgesia in the first 24 h postoperative will be calculated.
Pain score [24 hours postoperatively]
FLACC scale will used for postoperative pain assessment. This scale ranges from 0 to 10 where 0 represents no pain and 10 represents worst possible pain
The incidence of adverse effects [24 hours postoperatively]
Hypotension bradycardia, respiratory depression and vomiting will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 7 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karelsheikh University Hospital	Kafr Ash Shaykh	Karelsheikh	Egypt	33516

Sponsors and Collaborators

Kafrelsheikh University

Investigators

Principal Investigator: Kafrelsheikh University, Research ethics committee - Kafrelsheikh University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gamal Hendawy Shams, Lecturer, Kafrelsheikh University

ClinicalTrials.gov Identifier:

NCT05837000

Other Study ID Numbers:

MKSU 51- 2 - 16

First Posted:

May 1, 2023

Last Update Posted:

May 1, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 1, 2023