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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04331418
Enrollment
135
Registered
2020-04-02
Start date
2020-03-28
Completion date
2020-10-31
Last updated
2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexmedetomidine Infusion, Hypospadias Repair Surgery, Pediatric

Brief 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

Interventions

DRUGDexmedetomidine

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

PROCEDUREcaudal 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

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
2 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

1. male children 2. american society of aneasthesia physical status grade I &II 3. patients aged from 2 years to 12 years 4. patients will undergoing hypospadias repair surgery

Exclusion criteria

1. history or evidence of infection at the back 2. allergy to the study drugs 3. bleeding/coagulation disorder 4. developmental delay 5. septic patients 6. neurological or spinal diseases.

Design outcomes

Primary

MeasureTime frameDescription
quality of recovery of the studied patientsin immediate recovery from aneasthesia at postaneathetic care unit up to 2 hoursquality of recovery of the studied patients using modified objective pain score

Secondary

MeasureTime frameDescription
number of patients developed perioperative complications.in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unitnumber of patients developed perioperative complications
concentration of required postoperative analgesicin immediate recovery from aneasthesia up to 2 hours at postaneathetic care unitconcentration of postoperative analgesic
concentration of required postoperative sedationin immediate recovery from aneasthesia up to 2 hours at postaneathetic care unitconcentration of required postoperative sedation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026