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Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

Primary Purpose

Inguinal Hernia, Cryptorchidism

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Caudal Dexmedetomidine
Intravenous Dexmedetomidine
Placebo
sevoflurane
Sponsored by
Yao Yusheng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inguinal Hernia focused on measuring Dexmedetomidine, Postoperative pain reaction, anesthesia, children

Eligibility Criteria

2 Years - 5 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian Provincial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Caudal Dexmedetomidine

Intravenous Dexmedetomidine

Placebo

Arm Description

Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane

Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane

Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane

Outcomes

Primary Outcome Measures

Time to first rescue medication
the Children and Infants Postoperative Pain Scale (CHIPPS)

Secondary Outcome Measures

the number of patients not requiring rescue analgesia
the quality of postoperative pain control
the sedation score
sedation was assessed using the Modified Ramsay Sedation Score
Residual motor block
the degree of motor blockade was assessed using a modified Bromage scale
the incidence of emergence agitation
The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)
side effects
side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention
Pain intensity
Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)

Full Information

First Posted
October 2, 2012
Last Updated
November 13, 2018
Sponsor
Yao Yusheng
Collaborators
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01701778
Brief Title
Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
Official Title
Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yao Yusheng
Collaborators
West China Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Cryptorchidism
Keywords
Dexmedetomidine, Postoperative pain reaction, anesthesia, children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caudal Dexmedetomidine
Arm Type
Experimental
Arm Description
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane
Arm Title
Intravenous Dexmedetomidine
Arm Type
Experimental
Arm Description
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane
Intervention Type
Drug
Intervention Name(s)
Caudal Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline
Intervention Type
Drug
Intervention Name(s)
Intravenous Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Levobupivacaine
Intervention Description
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Intervention Description
Induction and maintain anaesthesia
Primary Outcome Measure Information:
Title
Time to first rescue medication
Description
the Children and Infants Postoperative Pain Scale (CHIPPS)
Time Frame
From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h
Secondary Outcome Measure Information:
Title
the number of patients not requiring rescue analgesia
Description
the quality of postoperative pain control
Time Frame
After surgery,up to 24h
Title
the sedation score
Description
sedation was assessed using the Modified Ramsay Sedation Score
Time Frame
After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h
Title
Residual motor block
Description
the degree of motor blockade was assessed using a modified Bromage scale
Time Frame
After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h
Title
the incidence of emergence agitation
Description
The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)
Time Frame
Participants will be followed for the duration of PACU stay, an expected average of 2 hours
Title
side effects
Description
side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention
Time Frame
From the administration of the caudal block until the end of study period, assessed up to postoperative 24h
Title
Pain intensity
Description
Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)
Time Frame
after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yusheng Yao, M.D.
Organizational Affiliation
Fujian Provincial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanqing Chen, M.D.
Organizational Affiliation
Fujian Provicial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin Liu, M.D.
Organizational Affiliation
West China Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30302881
Citation
Yao Y, Yu C, Zhang X, Guo Y, Zheng X. Caudal and intravenous dexmedetomidine similarly prolong the duration of caudal analgesia in children: A randomized controlled trial. Paediatr Anaesth. 2018 Oct;28(10):888-896. doi: 10.1111/pan.13469.
Results Reference
derived
Links:
URL
http://bja.oxfordjournals.org/content/103/2/268.full
Description
Addition of clonidine or dexmedetomidine to bupivacaine prolongs caudal analgesia in children

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Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

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