Skip to main content
OpenTrials
Completed

NCT Number: NCT04331418

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Abdelrahman

Tanta, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Dexmedetomidine

Drug

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

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.

Primary outcomes

  1. quality of recovery of the studied patients

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

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

  2. quality of recovery of the studied patients

    Time frame: 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 outcomes

  1. concentration of required postoperative analgesic

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

    concentration of postoperative analgesic

  2. concentration of required postoperative analgesic

    Time frame: from discharge from PACU up to 6 hours in the surgical ward

    concentration of required postoperative analgesic

  3. concentration of required postoperative sedation

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

    concentration of required postoperative sedation

  4. concentration of required postoperative sedation

    Time frame: from discharge from PACU up to 6 hours in the surgical ward

    concentration of required postoperative sedation

  5. number of patients developed perioperative complications.

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

    number of patients developed perioperative complications

  6. number of patients developed perioperative complications.

    Time frame: from discharge from PACU up to 6 hours in the surgical ward

    number of patients developed perioperative complications

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2020
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.