Clinical trial NCT01701778: Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
Official title: Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inguinal Hernia
Cryptorchidism
Keywords: Dexmedetomidine
Postoperative pain reaction
anesthesia
children
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital
First posted: 2012-10-05
Enrollment: 90
Sex: MALE
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to first rescue medication
timeFrame: From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h
Secondary outcomes:
measure: the number of patients not requiring rescue analgesia
timeFrame: After surgery,up to 24h
measure: the sedation score
timeFrame: After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h
measure: Residual motor block
timeFrame: After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h
measure: the incidence of emergence agitation
timeFrame: Participants will be followed for the duration of PACU stay, an expected average of 2 hours
measure: side effects
timeFrame: From the administration of the caudal block until the end of study period, assessed up to postoperative 24h
measure: Pain intensity
timeFrame: after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Yusheng Yao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fujian Provicial Hospital
name: Yanqing Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Jin Liu, M.D.
role: STUDY_DIRECTOR
References:
citation: Yao Y, Yu C, Zhang X, Guo Y, Zheng X. Caudal and intravenous dexmedetomidine similarly prolong the duration of caudal analgesia in children: A randomized controlled trial. Paediatr Anaesth. 2018 Oct;28(10):888-896. doi: 10.1111/pan.13469.