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

Not Applicable

Completed

• Conditions: Dexmedetomidine Infusion; Hypospadias Repair Surgery; Pediatric
• Interventions: Procedure: caudal block; Drug: Dexmedetomidine

• Registration Number: NCT04331418
• Lead Sponsor: Tanta University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-27
• Study Start: 2020-03-28
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-02
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
caudal group	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.
dexmetomidine group	Dexmedetomidine	Children in this group will be received (1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr) with a suggested maximum dose of 2 mcg/kg.of dexmedetomidine is available in a 100 mcg/mL concentration in a 2 mL preservative-free vial. It may be prepared as a 2 to 4 mcg/mL solution using normal saline

Primary Outcome Measures

Name	Time	Method
quality of recovery of the studied patients	from discharge from PACU up to 6 hours in the surgical ward	change in quality of recovery of the studied patients using modified objective pain score

Secondary Outcome Measures

Name	Time	Method
concentration of required postoperative analgesic	from discharge from PACU up to 6 hours in the surgical ward	concentration of required postoperative analgesic
concentration of required postoperative sedation	from discharge from PACU up to 6 hours in the surgical ward	concentration of required postoperative sedation
number of patients developed perioperative complications.	from discharge from PACU up to 6 hours in the surgical ward	number of patients developed perioperative complications

Trial Locations

Locations (1)

Ahmed Abdelrahman; 🇪🇬 Tanta, Egypt