Clinical trial

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

Name
precedex infusion in pediatric
Description
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
Trial arms
Trial start
2020-03-28
Estimated PCD
2020-10-31
Trial end
2020-10-31
Status
Completed
Treatment
Dexmedetomidine
1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr
Arms:
dexmetomidine 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.
Arms:
caudal group
Size
135
Primary endpoint
quality of recovery of the studied patients
in immediate recovery from aneasthesia at postaneathetic care unit up to 2 hours
quality of recovery of the studied patients
from discharge from PACU up to 6 hours in the surgical ward
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 135, 'type': 'ACTUAL'}}
Updated at
2023-11-24

1 organization

1 product

3 indications

Organization
Tanta University
Indication
Pediatric