The Effect of Premedication Type(Pharmalogical and Non Pharmalogical) on Delirium (EDIRA)

February 1, 2018 updated by: Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital

The Effect of Three Different Interventions on the Recovery Agitation and Delirium in the Pacu Pediatric Patients

Compare the effects of pharmacologic and nonpharmacologic premedications on postoperative emergence delirium and preoperative anxiety, vital parameters, blood pressure, heart rate, SpO2, and pain at PACU 15 minutes after adenotonsillectomy .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Compare the effects of

0.5 mg/kg oral midazolam,

watching film "Suko is being operated 'animation film (http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) and

playing a game named "fishing games" on postoperative emergency delirium by PAED (post anestesic emergency delirium) scale at PACU at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.

Investigators also evaluated "Basic and 20 minutes after pharmacologic and nonpharmacolgic premedications on participitans anxiety by Modified Yale Preoperative Anxiety Scale m-YPAS scores"

Pain evaluated by FLACC (behoviaral pain assesment scale),at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.

Blood pressure(mmHg), heart rate(beat/min) and SpO2(%) measured and recorded at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06610
        • Reyhan Polat

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 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II
  • Pediatric patients
  • Elective surgery
  • Adenotonsillectomi

Exclusion Criteria:

  • Cronicdesease
  • Mental retarde
  • Hearing and visual impaired
  • Prematurite

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral midazolam (Demizolam®)
To prevent emergence agitation patient premedicated by 0.5 mg oral midazolam At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale).
Other: Oral midazolam
0.5 mg/kg oral midazolam administered 20 minutes before induction
Other Names:
  • Demizolam
Active Comparator: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
To prevent emergence agitation patient premedicated by watching a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale).
Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) 20 minutes before induction.
Active Comparator: Play game (PC fishing game)
To prevent emergence agitation patient premedicated by playing a simple PC game (fishing game) At the end of sugery patients postoperatif emergence agitation evaluated PAED(pediatric anesthesia emergence delirium scale).
Other: Play game (PC fishing game)
Patients will be played a simple PC game (a fishing game) 20 minutes before induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergence agitation
Time Frame: Postoperative every 5 minutes for 15 minutes
Emergence agitation will be evaluated by PAED (pediatric anesthesia emergence dellirium).The PAED scale consists of five behaviors, each of which is rated on a five-level scale with a score of zero to four. The scores are added to achieve a total scale score (maximum value is 20). The score above 12 is significant for post operative emergence agitation.
Postoperative every 5 minutes for 15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preoperative anxiety
Time Frame: 20 minutea after premedications.
Preoperative anxiety will be evaluated by Modified Yale Preoperative Anxiety Scale ( m-YPAS )scores. Range between 23 to 100. m-YPAS score above 30 is significant to patients anxiety.
20 minutea after premedications.
Post operative pain
Time Frame: Postoperative every 5 minutes for 15 minutes

Postoperative pain will be evaluated by behavioral pain scale FLACC(behavioral pain assesment scale). Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0 = Relaxed and comfortable.

1 - 3 = mild discomfort 4 - 6 = moderate pain 7 - 10 = Severe discomfort or pain or both
Postoperative every 5 minutes for 15 minutes
Mean arteriel pressure
Time Frame: Postoperative every 5 minutes for15 minutes
Mean arteriel pressure, will be measured. Mean blood pressurre range between 66 to 73 mm Hg is considered normal value. 20% increase in baseline value is considered significant.
Postoperative every 5 minutes for15 minutes
Heart rate
Time Frame: Postoperative every 5 minutes for15 minutes.
Heart rate range between 80 to 120 beats/minute is considered normal value. %20 percent increase in baseline value is considered significant.
Postoperative every 5 minutes for15 minutes.

Collaborators and Investigators

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

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

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 (Anticipated)

February 20, 2018

Primary Completion (Anticipated)

May 30, 2018

Study Completion (Anticipated)

June 10, 2018

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

February 1, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27/11/2017 43/20
  • Ministry of health (Sevcan Arzu ARINKAN-2020-05-03T22_54_16)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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