Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children
1 other identifier
interventional
84
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJuly 28, 2016
July 1, 2016
11 months
July 26, 2016
July 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission
PAED score is assessed
1 min after postanesthesia care unit (PACU) admission
Secondary Outcomes (7)
Face legs activity cry consolability (FLACC) score
1 min after postanesthesia care unit (PACU) admission
PAED score 10 min after PACU admission
10 min after postanesthesia care unit (PACU) admission
PAED score 20 min after PACU admission
20 min after postanesthesia care unit (PACU) admission
PAED score 30 min after PACU admission
30 min after postanesthesia care unit (PACU) admission
FLACC score 10 min after PACU admission
10 min after postanesthesia care unit (PACU) admission
- +2 more secondary outcomes
Study Arms (2)
Normal Saline
PLACEBO COMPARATOR1\*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.
Ropivacaine
EXPERIMENTAL1\*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.
Interventions
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.
Eligibility Criteria
You may qualify if:
- American Society of anesthesiologist physical status class I/II
- tonsillectomy or adenotonsillectomy under general anesthesia
You may not qualify if:
- obstructive sleep apnea
- developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical assistant professor, primary investigator
Study Record Dates
First Submitted
July 26, 2016
First Posted
July 28, 2016
Study Start
August 1, 2016
Primary Completion
July 1, 2017
Study Completion
August 1, 2017
Last Updated
July 28, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share