Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery

Sponsor

Zonguldak Bulent Ecevit University (Other)

Overall Status

Completed

CT.gov ID

NCT05802082

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Preoperative Anxiety Postoperative Delirium	Other: The Modified Yale Preoperative Anxiety Scale (m-YPAS) of children

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

64 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

The Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Group P: n: 32patients Group P: Patients administered iv 10mg/kg paracetamol 30 minutes before surgery	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 Other Names: Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes. The Wong Baker Facial Pain Scale (WBYAS) is used to evaluate postoperative pain in children.
Group K:n:32 patients Group K: Patients administered iv 10mg/kg paracetamol 15 minutes before the end of surgery	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 Other Names: Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes. The Wong Baker Facial Pain Scale (WBYAS) is used to evaluate postoperative pain in children.

Arm

Intervention/Treatment

Group P: n: 32patients

Group P: Patients administered iv 10mg/kg paracetamol 30 minutes before surgery

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

Other Names:

Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes.

The Wong Baker Facial Pain Scale (WBYAS) is used to evaluate postoperative pain in children.

Group K:n:32 patients

Group K: Patients administered iv 10mg/kg paracetamol 15 minutes before the end of surgery

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

Other Names:

Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes.

The Wong Baker Facial Pain Scale (WBYAS) is used to evaluate postoperative pain in children.

Outcome Measures

Primary Outcome Measures

Preoperative Anxiety on Postoperative Delirium in Adenotonsillectomy Surgery [During the first 2 hours postoperatively]
The relationship between the mYPAS values of the groups and the PAED scores and Wong Baker Facial Pain Scale values
Preemptive analgesia on Postoperative Delirium in Adenotonsillectomy Surgery [During the first 2 hours postoperatively]
The relationship between the mYPAS values of the groups and the PAED scores and Wong Baker Facial Pain Scale values

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zonguldak Bülent Ecevit University	Zonguldak	Kozlu	Turkey	67600

Sponsors and Collaborators

Zonguldak Bulent Ecevit University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gamze Küçükosman, medical doctor, Zonguldak Bulent Ecevit University

ClinicalTrials.gov Identifier:

NCT05802082

Other Study ID Numbers:

2019/10

First Posted:

Apr 6, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Anxiety Disorders

Anesthetics

Study Results

No Results Posted as of Apr 6, 2023