Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Preoperative Anxiety
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Turkey
  • Kozlu
    • Zonguldak, Kozlu, Turkey, 67600
      • Zonguldak Bülent Ecevit University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

64

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Zonguldak Bulent Ecevit University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Anxiety Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2019/10

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