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

Pediatric Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331418
• Other study ID #: precedex infusion in pediatric
• Status: Completed
• Phase: N/A
• Start date: March 28, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dexmedetomidine Infusion
• Hypospadias
• Hypospadias Repair Surgery
• Pediatric

Intervention

Drug:
• Dexmedetomidine
1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr

Procedure:
• 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.

Locations

Country	Name	City	State
Egypt	Ahmed Abdelrahman	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	concentration of required postoperative analgesic	concentration of postoperative analgesic	in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
Secondary	concentration of required postoperative analgesic	concentration of required postoperative analgesic	from discharge from PACU up to 6 hours in the surgical ward
Secondary	concentration of required postoperative sedation	concentration of required postoperative sedation	in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
Secondary	concentration of required postoperative sedation	concentration of required postoperative sedation	from discharge from PACU up to 6 hours in the surgical ward
Secondary	number of patients developed perioperative complications.	number of patients developed perioperative complications	in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
Secondary	number of patients developed perioperative complications.	number of patients developed perioperative complications	from discharge from PACU up to 6 hours in the surgical ward