Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
- Conditions
- Inguinal HerniaCryptorchidism
- Interventions
- Registration Number
- NCT01701778
- Lead Sponsor
- Yao Yusheng
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 90
- ASA status I-II
- aged 2-5 yr
- Undergoing unilateral orchiopexy/inguinal hernia repair
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Caudal Dexmedetomidine sevoflurane Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane Intravenous Dexmedetomidine Intravenous Dexmedetomidine Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane Placebo Placebo Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane Caudal Dexmedetomidine Caudal Dexmedetomidine Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane Placebo sevoflurane Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane Intravenous Dexmedetomidine sevoflurane Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane
- Primary Outcome Measures
Name Time Method Time to first rescue medication 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)
- Secondary Outcome Measures
Name Time Method the number of patients not requiring rescue analgesia After surgery,up to 24h the quality of postoperative pain control
the sedation score 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
Residual motor block 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
the incidence of emergence agitation 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)
side effects 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
Pain intensity 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)
Trial Locations
- Locations (1)
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China