Back to resultsInfluence 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
About this trial
This is an interventional prevention trial for Tonsillitis
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
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
NCT ID
NCT02848287
First Posted
July 26, 2016
Last Updated
July 26, 2016
Sponsor
Ajou University School of Medicine
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
We'll reach out to this number within 24 hrs