Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children

Not Applicable

• Conditions: Tonsillitis
• Interventions: Drug: normal saline; Drug: ropivacaine

• Registration Number: NCT02848287
• Lead Sponsor: Ajou University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-28
• Last Update Posted: 2016-07-28
• Study Start: 2016-08
• Primary Completion: 2017-07
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	normal saline	1\*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.
Ropivacaine	ropivacaine	1\*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.

Primary Outcome Measures

Name	Time	Method
Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission	1 min after postanesthesia care unit (PACU) admission	PAED score is assessed

Secondary Outcome Measures

Name	Time	Method
Face legs activity cry consolability (FLACC) score	1 min after postanesthesia care unit (PACU) admission	FLACC score is assessed.
FLACC 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
PAED score 10 min after PACU admission	10 min after postanesthesia care unit (PACU) admission
FLACC 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
FLACC score 30 min after PACU admission	30 min after postanesthesia care unit (PACU) admission