Effect of Induction Method in Post Operative Agitation

September 30, 2019 updated by: Kevser Peker, Ahi Evran University Education and Research Hospital

the Effect of Two Different Method; Mask Ventilation or Intravenous Canulation on Emergence Agitation and Recovery Conditions on Pediatric Adenotonsillectomy

To compare the effect of two different induction method; mask ventilation and intravenous cannulation on emergence agitation on pediatric adenotonsillectomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many things cause emergence agitation after operations on pediatric population. This research aims determine which method, mask ventilation or intravenous cannulatin is more effective on emergence agitation

Study Type

Interventional

Enrollment (Actual)

67

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.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Dışkapı Yıldırım Beyazıt Education and Research Hospital
      • Kırşehir, Turkey
        • Ahi Evran University Education and Research Hospital

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

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pediatric adenotonsillectomy

Exclusion Criteria:

  • patients with neurological, hepatic, renal disorders and using any drugs

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mask ventilation
induction is made with mask ventilation
Device: mask ventilation
before intravenous induction, mask application is made. then intravenous cannulation and induction
Other Names:
  • induction method with mask ventilation
Device: intravenous cannulation
induction is applied by using intravenous cannulation
Other Names:
  • induction method with intravenous cannulation
Experimental: intravenous induction
induction is made with intravenous cannulation
Device: intravenous cannulation
induction is applied by using intravenous cannulation
Other Names:
  • induction method with intravenous cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess changing in pediatric agitation/ emergence delirium scale(PAED) scores
Time Frame: postoperative first hour
to asses change of intensity of postoperative emergence agitation/ delirium (PAED) by using pediatric agitation emergence delirium scale with scores. to assess changing PAED scores at one hour after transfer into the post anesthesia care unit.
postoperative first hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FLACC (face, legs,activity, cry, consolobility)
Time Frame: postoperative first hour
to asses postoperative pain intensity with scores by FLACC (face, legs,activity, cry, consolobility) scale after transfer into the post anesthesia care unit
postoperative first hour

Collaborators and Investigators

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

Sponsor

Ahi Evran University Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 2, 2017

Primary Completion (Actual)

October 30, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (Actual)

August 17, 2017

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • emergence agitation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Emergence Agitation

Clinical Trials on mask ventilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe