Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

November 13, 2018 updated by: Yao Yusheng

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Precedex
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: sevoflurane
Induction and maintain anaesthesia
Drug: Intravenous Dexmedetomidine

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: dexmedetomidine 1µg/kg

Other Names:
  • Precedex
Placebo Comparator: Placebo

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: 10 ml normal saline

Anesthesia was induced and maintained with sevoflurane
Drug: sevoflurane
Induction and maintain anaesthesia
Drug: Placebo

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: 10 ml normal saline

Other Names:
  • Levobupivacaine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to first rescue medication
Time Frame: 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)
From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the number of patients not requiring rescue analgesia
Time Frame: After surgery,up to 24h
the quality of postoperative pain control
After surgery,up to 24h
the sedation score
Time Frame: 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
After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h
Residual motor block
Time Frame: 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
After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h
the incidence of emergence agitation
Time Frame: 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)
Participants will be followed for the duration of PACU stay, an expected average of 2 hours
side effects
Time Frame: 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
From the administration of the caudal block until the end of study period, assessed up to postoperative 24h
Pain intensity
Time Frame: 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)
after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yao Yusheng

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
West China Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yanqing Chen, M.D., Fujian Provicial Hospital
  • Study Director: Jin Liu, M.D., West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FujianPH
  • FujianPH-TRC-121002 (Registry Identifier: Fujian Provicial Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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