Inguinal Hernia, Cryptorchidism
Conditions
Keywords
Dexmedetomidine, Postoperative pain reaction, anesthesia, children
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.
Interventions
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg
DRUGPlacebo
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline
DRUGsevoflurane
Induction and maintain anaesthesia
Sponsors
West China Hospital
Yao Yusheng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
2 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 number of patients not requiring rescue analgesia | After surgery,up to 24h | the quality of postoperative pain control |
| 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) |
| 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) |
Countries
China
Outcome results
None listed