Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Caudal Dexmedetomidine Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane |
Drug: Caudal Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg
Intravenous: 10 ml normal saline
Other Names:
Drug: sevoflurane
Induction and maintain anaesthesia
|
| Experimental: Intravenous Dexmedetomidine Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane |
Drug: Intravenous Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: dexmedetomidine 1µg/kg
Other Names:
Drug: sevoflurane
Induction and maintain anaesthesia
|
| Placebo Comparator: Placebo Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane |
Drug: Placebo
Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: 10 ml normal saline
Other Names:
Drug: sevoflurane
Induction and maintain anaesthesia
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fujian Provincial Hospital | Fuzhou | Fujian | China | 350001 |
Sponsors and Collaborators
- Yao Yusheng
- West China Hospital
Investigators
- Principal Investigator: Yusheng Yao, M.D., Fujian Provincial Hospital
- Principal Investigator: Yanqing Chen, M.D., Fujian Provicial Hospital
- Study Director: Jin Liu, M.D., West China Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Addition of clonidine or dexmedetomidine to bupivacaine prolongs caudal analgesia in children
- Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics
Publications
None provided.- FujianPH
- FujianPH-TRC-121002