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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06097169
• Other study ID #: E-10840098-772.02-6155
• Status: Completed
• Start date: October 10, 2023
• Est. completion date: February 25, 2024

Study information

• Verified date: February 2024
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 25, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

Exclusion Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anxiety
• Nausea
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Fentanyl
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.
• Dexmedetomidine
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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & 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. 2023 Jul 21. doi: 10.1213/ANE.0000000000006626. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.