Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
NCT Number: NCT01701778
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.
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Notify Me2 year–5 year
Male
Interventional
Phase 2
Fuzhou, Fujian, 350001, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg
Intravenous: 10 ml normal saline
Other names: Precedex
Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: dexmedetomidine 1µg/kg
Other names: Precedex
Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: 10 ml normal saline
Other names: Levobupivacaine
Induction and maintain anaesthesia
Time frame: From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h
the Children and Infants Postoperative Pain Scale (CHIPPS)
Time frame: After surgery,up to 24h
the quality of postoperative pain control
Time frame: After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h
sedation was assessed using the Modified Ramsay Sedation Score
Time frame: After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h
the degree of motor blockade was assessed using a modified Bromage scale
Time frame: Participants will be followed for the duration of PACU stay, an expected average of 2 hours
The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)
Time frame: From the administration of the caudal block until the end of study period, assessed up to postoperative 24h
side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention
Time frame: after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h
Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)
Yao Yusheng
Other
Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
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