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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05802082
Other study ID # 2019/10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date October 1, 2020

Study information

Verified date March 2023
Source Zonguldak Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The effects of preoperative anxiety and preemptive analgesia on PAED in children undergoing adenotonsillectomy surgery.


Description:

It is known that the frequency of postoperative delirium increases in children with preoperative anxiety. The Modified Yale Preoperative Anxiety Inventory (m-YPAS) was developed as a tool to assess children's preoperative anxiety, and m-YPAS≥30 was considered 'anxious'. Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes. There are factors such as inhalation agents, preoperative anxiety and postoperative pain in its etiology.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 2 Years to 10 Years
Eligibility Inclusion Criteria: - 2-10 years old, - ASA I-II risk group - Those who will be operated under general anesthesia under elective conditions. - Will undergo surgery for adenoidectomy and/or tonsillectomy - Patients whose informed consent form was read to their parents and their consent was obtained Exclusion Criteria: - Those whose families do not want to participate in the study, - ASA III -IV-V patients - Having a history of drug allergy and drug interaction, - Having a history of systemic disease such as heart, kidney, liver failure, - Having a history of bleeding diathesis, - Difficult intubation expected, - Obese, - Emergency patients, - Mental-motor retarded, - Having psychiatric and neurological diseases, - Those with chronic drug use

Study Design


Intervention

Other:
The Modified Yale Preoperative Anxiety Scale (m-YPAS) of children
Postoperative 0,5,10,15,30,45,60.and 120 minutes , PAED and WBYAS values

Locations

Country Name City State
Turkey Zonguldak Bülent Ecevit University Zonguldak Kozlu

Sponsors (1)

Lead Sponsor Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preoperative Anxiety on Postoperative Delirium in Adenotonsillectomy Surgery The relationship between the mYPAS values of the groups and the PAED scores and Wong Baker Facial Pain Scale values During the first 2 hours postoperatively
Primary Preemptive analgesia on Postoperative Delirium in Adenotonsillectomy Surgery The relationship between the mYPAS values of the groups and the PAED scores and Wong Baker Facial Pain Scale values During the first 2 hours postoperatively
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