Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children

Study Overview
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Brief Summary
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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.

Official Title
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Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Preschool-aged Children Undergoing Adenotonsillectomy

Conditions
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Tonsillitis

Intervention / Treatment
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* Drug: normal saline
* Drug: ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal Saline<br>1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed. | Drug: normal saline<br>* 1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.<br>|
| Experimental: Ropivacaine<br>1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed. | Drug: ropivacaine<br>* 1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission | PAED score is assessed | 1 min after postanesthesia care unit (PACU) admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Face legs activity cry consolability (FLACC) score | FLACC score is assessed. | 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 | 
| FLACC score 20 min after PACU admission |  | 20 min after postanesthesia care unit (PACU) admission | 
| FLACC score 30 min after PACU admission |  | 30 min after postanesthesia care unit (PACU) admission |