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Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery

NCT04331418 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2023-11-24

No results posted yet for this study

Summary

Pain is one of the most misunderstood, underdiagnosed, and untreated medical problems, particularly in children. New Joint Commission on Accreditation of Health Care Organization regards pain as fifth vital sign and requires caregivers to regularly assess pain. Inadequate pain relief during childhood may have long-term negative effects including harmful neuroendocrine responses disrupted eating and sleep cycles and increased pain perception during subsequent painful experiences. Also, postoperative pain can result in an uncooperative and restless child. Hence, it is preferable to prevent the onset of pain rather than to relieve its existence.

Various multimodal techniques have been designed for pediatric pain relief. These include both systemic and regional analgesia. The most commonly used regional technique is caudal epidural block. Advantages of the caudal block are smoother recovery with less distress behavior, early ambulation, decreased the risk of chest infections, decreased postoperative analgesic requirements, and early discharge.

In our culture; considerable number of parents still refuses caudal anesthesia fearing from the rare neurological sequelae may occur. This the motive for searching for parenteral surrogate gives clear headed recovery resembles regional analgesia.

Dexmedetomidine is an alpha 2 agonist which has sedative, analgesic, and opioid-sparing effect. It prolongs the duration of analgesia by its local vasoconstrictive effect and by increasing the potassium conductance in A-delta and C-fibers.

It also exerts its analgesic action centrally via systemic absorption or by diffusion into the cerebrospinal fluid and reaches alpha 2 receptors in the superficial laminae of the spinal cord and brainstem or indirectly activating spinal cholinergic neurons. The sedative effects of dexmedetomidine are mostly due to stimulation of the alpha 2 adrenoceptor in the locus coeruleus

Conditions

  • Dexmedetomidine Infusion
  • Pediatric
  • Hypospadias Repair Surgery

Interventions

DRUG

Dexmedetomidine

1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr

PROCEDURE

caudal block

After negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-28
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • Egypt

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 NCT04331418 on ClinicalTrials.gov