Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

Yao Yusheng

Status and phase: Completed; Phase 2

Conditions: Cryptorchidism; Inguinal Hernia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01701778

FujianPH-TRC-121002 (Registry Identifier)

FujianPH

Details and patient eligibility

About

The purpose of this study is to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower abdominal surgeries.

Full description

Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures.However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves.

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 clonidine 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 levobupivacaine for inguinal herniorrhaphy or orchidopexy surgery.

90 children (ASAⅠorⅡ,aged 2-5 yr) undergoing unilateral orchiopexy or inguinal herniorrhaphy 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 Cau-DEX (n = 30): Caudal Levobupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group IV-DEX(n = 30): Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group Placebo(n = 30): Levobupivacaine 0.25% and 10 ml normal saline intravenous.

Enrollment: 90 patients

Sex: Male

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA status I-II
• aged 2-5 yr
• Undergoing unilateral orchiopexy/inguinal hernia repair

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
• Diabetes mellitus
• Children with uncorrected cardiac lesions
• Children with heart block or liver impairment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Caudal Dexmedetomidine

Experimental group

Description:

Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane

Treatment:

Drug: Caudal Dexmedetomidine

Drug: sevoflurane

Intravenous Dexmedetomidine

Experimental group

Description:

Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane

Treatment:

Drug: sevoflurane

Drug: Intravenous Dexmedetomidine

Placebo

Placebo Comparator group

Description:

Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane

Treatment:

Drug: sevoflurane

Drug: Placebo