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

NCT04331418 | Completed

• 1 other identifier: precedex infusion in pediatric
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• quality of recovery of the studied patients

  quality of recovery of the studied patients using modified objective pain score

  in immediate recovery from aneasthesia at postaneathetic care unit up to 2 hours

• quality of recovery of the studied patients

  change in quality of recovery of the studied patients using modified objective pain score

  from discharge from PACU up to 6 hours in the surgical ward

Secondary Outcomes (6)

• concentration of required postoperative analgesic

  in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit

• concentration of required postoperative analgesic

  from discharge from PACU up to 6 hours in the surgical ward

• concentration of required postoperative sedation

  in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit

• concentration of required postoperative sedation

  from discharge from PACU up to 6 hours in the surgical ward

• number of patients developed perioperative complications.

  in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit

Study Arms (3)

control group

NO INTERVENTION

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.

caudal group

EXPERIMENTAL

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.

Procedure: caudal block

dexmetomidine group

EXPERIMENTAL

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

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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

dexmetomidine group

caudal block 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.

caudal group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• history or evidence of infection at the back
• allergy to the study drugs
• bleeding/coagulation disorder
• developmental delay
• septic patients
• neurological or spinal diseases.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Ahmed Abdelrahman

Tanta, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 2, 2020
• Study Start: March 28, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)