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Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children

Primary Purpose

Tonsillitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
normal saline
ropivacaine
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tonsillitis

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of anesthesiologist physical status class I/II
  • tonsillectomy or adenotonsillectomy under general anesthesia

Exclusion Criteria:

  • obstructive sleep apnea
  • developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Normal Saline

    Ropivacaine

    Arm Description

    1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.

    1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.

    Outcomes

    Primary Outcome Measures

    Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission
    PAED score is assessed

    Secondary Outcome Measures

    Face legs activity cry consolability (FLACC) score
    FLACC score is assessed.
    PAED score 10 min after PACU admission
    PAED score 20 min after PACU admission
    PAED score 30 min after PACU admission
    FLACC score 10 min after PACU admission
    FLACC score 20 min after PACU admission
    FLACC score 30 min after PACU admission

    Full Information

    First Posted
    July 26, 2016
    Last Updated
    July 26, 2016
    Sponsor
    Ajou University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02848287
    Brief Title
    Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children
    Official Title
    Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Preschool-aged Children Undergoing Adenotonsillectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ajou University School of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are several preventive strategies but none of them completely prevent EA. Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might reduce the incidence of postoperative EA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tonsillitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    84 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal Saline
    Arm Type
    Placebo Comparator
    Arm Description
    1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.
    Arm Title
    Ropivacaine
    Arm Type
    Experimental
    Arm Description
    1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Intervention Description
    1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.
    Intervention Type
    Drug
    Intervention Name(s)
    ropivacaine
    Intervention Description
    1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.
    Primary Outcome Measure Information:
    Title
    Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission
    Description
    PAED score is assessed
    Time Frame
    1 min after postanesthesia care unit (PACU) admission
    Secondary Outcome Measure Information:
    Title
    Face legs activity cry consolability (FLACC) score
    Description
    FLACC score is assessed.
    Time Frame
    1 min after postanesthesia care unit (PACU) admission
    Title
    PAED score 10 min after PACU admission
    Time Frame
    10 min after postanesthesia care unit (PACU) admission
    Title
    PAED score 20 min after PACU admission
    Time Frame
    20 min after postanesthesia care unit (PACU) admission
    Title
    PAED score 30 min after PACU admission
    Time Frame
    30 min after postanesthesia care unit (PACU) admission
    Title
    FLACC score 10 min after PACU admission
    Time Frame
    10 min after postanesthesia care unit (PACU) admission
    Title
    FLACC score 20 min after PACU admission
    Time Frame
    20 min after postanesthesia care unit (PACU) admission
    Title
    FLACC score 30 min after PACU admission
    Time Frame
    30 min after postanesthesia care unit (PACU) admission

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of anesthesiologist physical status class I/II tonsillectomy or adenotonsillectomy under general anesthesia Exclusion Criteria: obstructive sleep apnea developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Go Un Roh, MD
    Phone
    82-31-219-6435
    Email
    gone7968@aumc.ac.kr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children

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