Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children

July 26, 2016 updated by: Go Un Roh, Ajou University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission
Time Frame: 1 min after postanesthesia care unit (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
Time Frame: 1 min after postanesthesia care unit (PACU) admission
FLACC score is assessed.
1 min after postanesthesia care unit (PACU) admission
PAED score 10 min after PACU admission
Time Frame: 10 min after postanesthesia care unit (PACU) admission
10 min after postanesthesia care unit (PACU) admission
PAED score 20 min after PACU admission
Time Frame: 20 min after postanesthesia care unit (PACU) admission
20 min after postanesthesia care unit (PACU) admission
PAED score 30 min after PACU admission
Time Frame: 30 min after postanesthesia care unit (PACU) admission
30 min after postanesthesia care unit (PACU) admission
FLACC score 10 min after PACU admission
Time Frame: 10 min after postanesthesia care unit (PACU) admission
10 min after postanesthesia care unit (PACU) admission
FLACC score 20 min after PACU admission
Time Frame: 20 min after postanesthesia care unit (PACU) admission
20 min after postanesthesia care unit (PACU) admission
FLACC score 30 min after PACU admission
Time Frame: 30 min after postanesthesia care unit (PACU) admission
30 min after postanesthesia care unit (PACU) admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-DRU-16-061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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