Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children
- Conditions
- Pain
- Interventions
- Registration Number
- NCT02416063
- Lead Sponsor
- University of Jordan
- Brief Summary
The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.
- Detailed Description
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 dexmedetomidine 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 bupivacaine in children undergoing infra-umbilical surgery.
75 children (ASAⅠorⅡ,aged 1-6 yr) undergoing infra-umbilical surgery 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 B-Dcau (n = 25): Caudal bupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group B-Div (n = 25): bupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group B(n = 25): bupivacaine 0.25% and 10 ml normal saline intravenous
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Patients with American Society of Anesthesiologists (ASA) - I
- Scheduled for lower abdominal and perineal surgery
- Under general anesthesia
- Hypersensitivity to any local anesthetics
- Patient has history of allergy, intolerance, or reaction to dexmedetomidine
- Infections at puncture sites
- Bleeding diathesis
- Preexisting neurological disease
- Children with uncorrected cardiac lesions
- Children with heart block
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description caudal Dexmedetomidine Caudal Dexmedetomidine Drug:Caudal Bupivacaine 0.25% 1ml/kg . Drug:caudal Dexmedetomidine 1μg /kg. Intravenous :10 ml normal saline Anesthesia was induced and maintained with sevoflurane Intravenous Dexmedetomidine Intravenous dexmedetomidine Drug:Caudal bupivacaine 0.25% 1ml/kg Drug: Intravenous dexmedetomidine 1µg/kg in a 10 ml volume normal saline Anesthesia was induced and maintained with sevoflurane Placebo Placebo Caudal: bupivacaine 0.25% 1ml/kg . Intravenous: 10 ml Normal saline Anesthesia was induced and maintained with sevoflurane
- Primary Outcome Measures
Name Time Method Time to first analgesic requirement 24 hours Time to first rescue medication. The time from end of surgery to the first requirement of postoperative analgesia,pain score ≥4
- Secondary Outcome Measures
Name Time Method the incidence of emergence agitation 2 hours Participants will be followed for the duration of PACU stay, an expected average of 2 hours
Postoperative behaviour scores 2 hours behaviour score was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals.
Blood pressure Perioperative blood pressure readings 2 hours Perioperative blood pressure readings
Side effects 24 hours side effects including nausea, vomiting and urinary retention and lower limb weakness
Sevoflurane concentration 1 hour Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60
Heart Rate 2 hours Perioperative heart rate readings
Postoperative pain scores 24 hours postoperative pain score will be assessed over 24 hours