Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery

Completed

• Conditions: Preoperative Anxiety; Postoperative Delirium
• Interventions: Other: The Modified Yale Preoperative Anxiety Scale (m-YPAS) of children

• Registration Number: NCT05802082
• Lead Sponsor: Zonguldak Bulent Ecevit University

Brief Summary

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

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 Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Study First Submitted: 2023-01-19
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-24
• Last Update Submitted: 2023-03-24
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group K:n:32 patients	The Modified Yale Preoperative Anxiety Scale (m-YPAS) of children	Group K: Patients administered iv 10mg/kg paracetamol 15 minutes before the end of surgery
Group P: n: 32patients	The Modified Yale Preoperative Anxiety Scale (m-YPAS) of children	Group P: Patients administered iv 10mg/kg paracetamol 30 minutes before surgery

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zonguldak Bülent Ecevit University; 🇹🇷 Zonguldak, Kozlu, Turkey