Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Dental Treatment

NCT06097169 | Completed DMC FDA Drug

• 1 other identifier: E-10840098-772.02-6155
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The purpose of this run is to use the association between this use during surgery and the attrition of post-operative pain and discomfort. In the research, laboratory and monitoring results will be obtained before, during and after the operation. Postoperative patient complaints will be evaluated at the postoperative service visit. This study is decided on a completely voluntary basis.

Conditions

Anxiety; Postoperative Pain; Nausea

Keywords

Dexmedetomidin; dental treatment; post operative anxiety

Outcome Measures

Primary Outcomes (2)

• postoperative pain

  Postoperative pain level will be measured using the FLACC pain scale (face, legs, activity, cry, consolability). 4 and above will be considered as high pain level, below 4 as low pain level.

  Pain was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.

• postoperative anxiety

  Postoperative anxiety level will be measured using the Pediatric Anesthesia Emergence Delirium Scale (PAED). A value of 12 and above will be considered high anxiety, and values below 12 will be considered low anxiety.

  anxiety was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.

Study Arms (2)

Dex

patients using dexmedetomidine infusion

Drug: Dexmedetomidine

Fen

patients using fentanyl for induction

Drug: Fentanyl

Interventions

Fentanyl DRUG

In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.

Also known as: Talinat

Fen

Dexmedetomidine DRUG

In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.

Also known as: Precedex

Dex

Eligibility Criteria

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

Study Population

Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included

You may not qualify if:

• Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included.
• developmental delay anxiety disorder Known history of allergy to alpha-2 agonistic agents use of antipsychotic medication beta blocker use of anticonvulsant drugs chronic pain syndrome with cardiac and craniofacial anomalies

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, 34400, Turkey (Türkiye)

Location

Related Publications (1)

• Zhou D, Yang XD, Wu HY, Xiong GL, Wang LK. Determination of the ED90 of Dexmedetomidine Infusion to Prevent Emergence Agitation in Children Undergoing Dental Rehabilitation With Sevoflurane Anesthesia: A Biased-Coin Up-and-Down Sequential Allocation Trial. Anesth Analg. 2024 Oct 1;139(4):761-769. doi: 10.1213/ANE.0000000000006626. Epub 2024 Jul 21.

  PMID: 37478025 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative; Nausea

Interventions

Fentanyl; Dexmedetomidine

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: October 10, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 25, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)