Paracetamol Plus Tramadol Versus Fentanyl in Day Case Surgeries

NCT05990686 | Recruiting

• 1 other identifier: 9702/19-10-2022
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is an important problem, especially for day case surgeries. It has negative effects on patient's hemodynamics and can cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction. Multiple analgesic strategies have been proposed including NSAID, opioids, epidural analgesia. Each of them has its limitations. In this study the investigators will compare between the effect of preemptive use of paracetamol plus tramadol versus preemptive intravenous fentanyl in controlling postoperative pain

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• postoperative analgesia

  Assess quality of postoperative analgesia in both groups analogue score (VAS) scale where zero means no pain and ten means worst pain

  immediately postoperative (0 hour), 1 hour, 2 hours , 4 hours, 6 hours and 12 hours

Secondary Outcomes (5)

• mean arterial Blood pressure

  5 minutes after start of surgery (intraoperative) , immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery

• rescue analgesic

  immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery

• side effects

  up to twenty four hours after surgery

• length of hospital stay

  up to twenty four hours after surgery

• Heart Rate

  5 minutes after start of surgery ( intraoperative), immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery

Study Arms (2)

paracetamol plus tramadol

randomized selection of 66 adult patients

Drug: Tramadol Hydrochloride

fentanyl

randomized selection of 66 adult patients

Drug: Fentanyl injection

Interventions

Tramadol Hydrochloride DRUG

After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, noninvasive blood pressure and electrocardiogram and baseline parameter will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started. Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and to be finished before starting of induction of anaesthesia (induction agent will be Propofol 2mg/kg)

Also known as: tramadol

paracetamol plus tramadol

Fentanyl injection DRUG

After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, noninvasive blood pressure and electrocardiogram and baseline parameter will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started...Intravenous injection of 1microgram/kg fentanyl will be given to the patient followed by induction agents ( propofol 2mg/kg). .

Also known as: fentanyl

fentanyl

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

patients scheduled for a day case surgeries

You may qualify if:

• Patients scheduled for day case surgeries.
• Both sex
• Patient's age 21 - 60 years.
• Patients with ASA physical status I, II.
• BMI 25 - 30 kg m-2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University , Fuculty of Medicine

Zagazig, Sharquia, 7120730, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol; Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• MICHAEL A shaker, lecturer

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

michael A shaker, lecturer

CONTACT

01220647566; michaeladelshaker@yahoo.com

salwa S el sherbeny, lecturer

CONTACT

01128595629; dr_salwa86@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 14, 2023
• Study Start: January 10, 2023
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

EG (1)