Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

Inguinal Hernia Clinical Trial

Official title:

Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701778
• Other study ID #: FujianPH
• Secondary ID: FujianPH-TRC-121
• Status: Completed
• Phase: Phase 2
• Start date: October 2012
• Est. completion date: January 2014

Study information

• Verified date: November 2018
• Source: Fujian Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryptorchidism
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Drug:
• Caudal Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline
• Intravenous Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg
• Placebo
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline
• sevoflurane
Induction and maintain anaesthesia

Locations

Country	Name	City	State
China	Fujian Provincial Hospital	Fuzhou	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
Yao Yusheng	West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first rescue medication	the Children and Infants Postoperative Pain Scale (CHIPPS)	From the administration of the caudal block to the first registration of a CHIPPS scores=4,assessed up to 24h
Secondary	the number of patients not requiring rescue analgesia	the quality of postoperative pain control	After surgery,up to 24h
Secondary	the sedation score	sedation was assessed using the Modified Ramsay Sedation Score	After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h
Secondary	Residual motor block	the degree of motor blockade was assessed using a modified Bromage scale	After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h
Secondary	the incidence of emergence agitation	The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)	Participants will be followed for the duration of PACU stay, an expected average of 2 hours
Secondary	side effects	side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention	From the administration of the caudal block until the end of study period, assessed up to postoperative 24h
Secondary	Pain intensity	Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)	after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h

External Links

•   Addition of clonidine or dexmedetomidine to bupivacaine prolongs caudal analgesia in children
•   Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics