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

Sponsor

Burak Omur (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05986942

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

26.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Postoperative Pain Bleeding	Drug: Fentanyl Drug: Dexmedetomidine

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Dex patients using dexmedetomidine infusion	Drug: 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. Other Names: Precedex
Fen patients using fentanyl for induction	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. Other Names: Talinat

Arm

Intervention/Treatment

Dex

patients using dexmedetomidine infusion

Drug: 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.

Other Names:

Precedex

Fen

patients using fentanyl for induction

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.

Other Names:

Talinat

Outcome Measures

Primary Outcome Measures

postoperative pain [Pain was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.]
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.
postoperative anxiety [anxiety was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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