Effect of Adding Different Concentrations of Dexmedetomidine to Bupivacaine in Caudal Block for Pediatrics

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age1-6
SponsorAssiut University

About this trial

Pain is one of the medical problems frequently misdiagnosed, undertreated, and poorly under-stood, particularly in children.Poor pain management during childhood may have long-term deleterious impacts, including damaging neuro-endocrine reactions, disturbed eating and sleeping pat-terns, and increased pain sensitivity during subsequent painful events.

A caudal epidural block is a common regional analgesic technique in pediatric surgery . It is a time-tested, safe, and efficacious technique However, the duration of post-operative pain seen with much pediatric surgery (\>24 h) outlasts the duration of analgesia afforded by a standard 'local-anesthetics only' caudal block (4-12 h) While continuous catheters prolong analgesic duration, such techniques are more cumbersome, require significant technical expertise and may be associated with higher adverse events. Contrary to this, adding adjuvants to local anesthetic is an appealing alternative. Adjuvants can improve the block and analgesic duration , reduce general anesthetic or local anesthetic requirements, allow for smoother emergence, lower incidence of emergence delirium, and facilitate early discharge in ambulatory surgery.

Various adjuvants have been shown to enhance caudal blocks with varying degrees of success. A multitude of clinical trials and meta-analyses have analyzed the efficacy of different adjuvants such as alpha-2 agonists (clonidine and dexmedetomidine ), N-methyl-D-aspartate (NMDA) antagonists (ketamine and magnesium ), opioids (fentanyl, morphine, and tramadol ), corticosteroids (dexamethasone ), and acetylcholine esterase inhibitors (neostigmine).

Dexmedetomidine has become more popular as a caudal adjuvant in children; it is a highly selective α2 agonist with sedative and analgesic properties. Dexmedetomidine possesses anxiolytic, sedative, sympatholytic, and analgesic properties without respiratory depressant effects In addition; dexmedetomidine has the ability to reduce both the anesthetic and opioid analgesic requirements during the perioperative period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA I and II,

aged 1-6 years

scheduled for elective inguinal hernia repair

Disqualifiers

Guardians refusal

Patients with congenital anomalies at the lower spine or meninges

Patients with increased intracranial pressure

Patients with skin infection at the site of injection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    Dexmedetomidine has become more popular as a caudal adjuvant in children; it is a highly selective α2 agonist with sedative and analgesic properties. Dexmedetomidine possesses anxiolytic, sedative, sympatholytic, and analgesic properties without respiratory depressant effects In addition; dexmedetomidine has the ability to reduce both the anesthetic and opioid analgesic requirements during the perioperative period.

  • Bupivacain

    Drug

    Bupivacaine is a potent local anesthetic with unique characteristics from the amide group of local anesthetics.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group A: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 0.Active comparator 2 interventions
Group B: Group B: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 1Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

The duration of analgesia

Time frame
baseline and 24 hours

Secondary outcomes

1

Total analgesic consumption

Time frame
baseline and 24 hours
2

any neurological adverse effects

Time frame
baseline and 24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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