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Postoperative Pain Relief in Children: Comparing Caudal Bupivacaine Alone Versus Bupivacaine With Dexmedetomidine for Infra-Umbilical Surgeries Under General Anesthesia

NCT07121764 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-13

No results posted yet for this study

Summary

This study is being done to find out which medicine combination provides better pain relief after surgery in children. Children who are having surgery below the belly button (called infra-umbilical surgery) will receive general anesthesia and a type of pain-blocking injection called a caudal block. This block helps reduce pain after surgery.

The study will compare two types of caudal injections:

One group will receive Bupivacaine alone, a commonly used local anesthetic.

The other group will receive Bupivacaine combined with Dexmedetomidine, a medicine that might help the pain relief last longer.

The main question the researchers want to answer is:

Does adding Dexmedetomidine to Bupivacaine increase the duration of pain relief after surgery in children?

Researchers will also look at:

How long it takes before the child needs the first dose of pain medicine after surgery

How much pain medicine is used in the first 24 hours

How long any movement problems (motor block) last

Whether there are any side effects

Each child will be randomly assigned (like flipping a coin) to one of the two groups. The caudal block will be done after the surgery is completed, while the child is still under anesthesia. The nurse assessing the child's pain will not know which medicine the child received.

Children will be monitored for pain using a standard scoring system (FLACC scale) every few hours after surgery. If the pain score is high (7 or more), the child will receive intravenous paracetamol. Researchers will record how long the pain relief lasts, when the first pain medicine is needed, and the total amount of pain medicine used in the first 24 hours.

The study aims to help doctors choose the most effective and safe method to reduce post-surgery pain in children.

Conditions

  • Hernia Repair
  • Orchiopexy
  • Hypospadias

Interventions

DRUG

Bupivacaine %0.25 (isobaric)

1 ml/kg of 0.25% Bupivacaine will be used for caudal block.

DRUG

Dexmedetomidine & Bupivacaine.

1 ml/kg of 0.25% Bupivacaine PLUS 1 μg/kg Dexmedetomidine in 1 ml Normal Saline will be used for caudal block.

Sponsors & Collaborators

  • Allama Iqbal Teaching Hospital

    lead OTHER_GOV

Principal Investigators

  • Syed A Abbas Naqvi, FCPS · Allama Iqbal Teaching Hospital Dera Ghazi Khan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-27
Primary Completion
2025-07-26
Completion
2025-07-26

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121764 on ClinicalTrials.gov