Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

Conditions
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Inguinal Hernia, Cryptorchidism

Intervention / Treatment
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* Drug: Caudal Dexmedetomidine
* Drug: Intravenous Dexmedetomidine
* Drug: Placebo
* Drug: sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caudal Dexmedetomidine<br>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<br>* Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline<br>* Other names: Precedex;Drug: sevoflurane<br>* Induction and maintain anaesthesia<br>|
| Experimental: Intravenous Dexmedetomidine<br>Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane | Drug: Intravenous Dexmedetomidine<br>* Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg<br>* Other names: Precedex;Drug: sevoflurane<br>* Induction and maintain anaesthesia<br>|
| Placebo Comparator: Placebo<br>Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane | Drug: Placebo<br>* Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline<br>* Other names: Levobupivacaine;Drug: sevoflurane<br>* Induction and maintain anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first rescue medication | the Children and Infants Postoperative Pain Scale (CHIPPS) | From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients not requiring rescue analgesia | the quality of postoperative pain control | After surgery,up to 24h | 
| the sedation score | sedation was assessed using the Modified Ramsay Sedation Score | After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h | 
| Residual motor block | the degree of motor blockade was assessed using a modified Bromage scale | After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h | 
| the incidence of emergence agitation | The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED) | Participants will be followed for the duration of PACU stay, an expected average of 2 hours | 
| side effects | side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention | From the administration of the caudal block until the end of study period, assessed up to postoperative 24h | 
| Pain intensity | Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS) | after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Postoperative pain reaction, anesthesia, children