Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries

Zagazig University

Status and phase: Invitation-only; Early Phase 1

Conditions: Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl

Treatments: Drug: propofol and muscle relaxant (cisatracurium); Drug: Propofol; Drug: Fentanyl; Drug: tramadol plus paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT06561672

459

Details and patient eligibility

About

Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.

Full description

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (T group and F group). Using computer generated randomization table; each group consists of 51 patients:Group (T) (n=51): Patients will receive preemptive intravenous infusion of tramadol plus paracetamol .

Group (F) (n=51): Patients will receive preemptive intravenous fentanyl.

Enrollment: 102 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for day case surgeries.
• Patient acceptance to be included into the study.
• Both sex.
• Patients with ASA physical status I, II.
• BMI 25 - 30 kg m-2.
• Duration of surgery from 1-2 hours

Exclusion criteria

-Uncooperative patients and patients with psychological problems.-

• Patients with liver or renal impairment.
• Patients with history of allergy to drug used in the study.
• Patients with chronic pain.
• Patient on pain therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

tramadol plus paracetamol (T)

Experimental group

Treatment:

Drug: tramadol plus paracetamol

Drug: propofol and muscle relaxant (cisatracurium)

fentanyl(F)

Experimental group

Treatment:

Drug: Propofol

Drug: Fentanyl