Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children

University of Jordan

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Intravenous dexmedetomidine; Drug: Caudal Dexmedetomidine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02416063

Faculty of medicine-JU

Details and patient eligibility

About

The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.

Full description

Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration of action of caudal block with a local anesthetic agent.But which route of administration of dexmedetomidine is the most beneficial remains unknown.

The investigators performed prospective randomized double-blind study to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after caudal bupivacaine in children undergoing infra-umbilical surgery.

75 children (ASAⅠorⅡ,aged 1-6 yr) undergoing infra-umbilical surgery were included in this study. Anesthesia was induced with sevoflurane via a facemask, followed by placement of a laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups. Group B-Dcau (n = 25): Caudal bupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group B-Div (n = 25): bupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group B(n = 25): bupivacaine 0.25% and 10 ml normal saline intravenous

Enrollment: 75 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with American Society of Anesthesiologists (ASA) - I
• Scheduled for lower abdominal and perineal surgery
• Under general anesthesia

Exclusion criteria

• Hypersensitivity to any local anesthetics
• Patient has history of allergy, intolerance, or reaction to dexmedetomidine
• Infections at puncture sites
• Bleeding diathesis
• Preexisting neurological disease
• Children with uncorrected cardiac lesions
• Children with heart block

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

caudal Dexmedetomidine

Active Comparator group

Description:

Drug:Caudal Bupivacaine 0.25% 1ml/kg . Drug:caudal Dexmedetomidine 1μg /kg. Intravenous :10 ml normal saline Anesthesia was induced and maintained with sevoflurane

Treatment:

Drug: Caudal Dexmedetomidine

Intravenous Dexmedetomidine

Active Comparator group

Description:

Drug:Caudal bupivacaine 0.25% 1ml/kg Drug: Intravenous dexmedetomidine 1µg/kg in a 10 ml volume normal saline Anesthesia was induced and maintained with sevoflurane

Treatment:

Drug: Intravenous dexmedetomidine

Placebo

Placebo Comparator group

Description:

Caudal: bupivacaine 0.25% 1ml/kg . Intravenous: 10 ml Normal saline Anesthesia was induced and maintained with sevoflurane

Treatment:

Drug: Placebo