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

NCT ID: NCT04331418

Last Updated: 2023-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-28
• Study Completion Date: 2020-10-31

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

Conditions

Dexmedetomidine Infusion; Pediatric; Hypospadias Repair Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

control group

On arrival to operating room, Noninvasive monitors, such as electrocardiography, noninvasive blood pressure (NIBP), oxygen saturation (SpO2), will be attached and baseline parameters such as heart rate, mean arterial pressure, and peripheral oxygen saturation will be recorded .

General anesthesia will be induced with O2/sevo (FiO2 = 1 /sevoflurane 8% MAC), cis-atracurium 0.1 mg/kg iv, +/- fentanyl 1 mcg/kg iv. Trachea will be intubated with an appropriate sized, endotracheal tube and maintenance of anesthesia by O2/Air (FiO2 = 0.4), sevoflurane 2% MAC.

Dexamethasone 0.15 mg/kg iv will be given as PONV prophylaxis. Increments of fentanyl 0.5 mcg/kg iv and cis-atracurium 0.03 mg/kg iv will be given according to hemodynamics and capnography.

Group Type: NO_INTERVENTION

No interventions assigned to this group

caudal group

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.

Group Type: EXPERIMENTAL

caudal block

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Amany Faheem

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Abdelrahman

Tanta, , Egypt

Countries

Egypt

Other Identifiers

precedex infusion in pediatric

Identifier Type: -

Identifier Source: org_study_id