Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery

NCT05802082 | Completed

• 1 other identifier: 2019/10
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preoperative Anxiety; Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

The Modified Yale Preoperative Anxiety Scale (m-YPAS) of children OTHER

Postoperative 0,5,10,15,30,45,60.and 120 minutes , PAED and WBYAS values

Also known as: 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 P: n: 32patients

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

64

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: April 6, 2023
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 6, 2023

Record last verified: 2023-03

Locations

TU (1)