Paracetamol Plus Tramadol Versus Fentanyl in Day Case Surgeries

Paracetamol Plus Tramadol Versus Fentanyl as Pre-emptive Analgesia for Enhanced Recovery After Day-Case Surgeries: A Randomised Controlled Trial

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 the effect of preemptive use of paracetamol plus tramadol versus preemptive intravenous fentanyl in controlling postoperative pain

Study Overview

• Status: Completed
• Conditions: Post Operative Pain; Preemptive Analgesia
• Intervention / Treatment: Drug: tramadol plus paracetamol; Drug: Fentanyl Injection

Detailed Description

After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, non invasive blood pressure and electrocardiogram and baseline parameters 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.

Patients will be randomly allocated into two equal groups:

- Group (T) (n=51): Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and finished before the start of induction of anesthesia

- Group ( F ) (n=51): Intravenous injection of 1.5 microgram/kg fentanyl will be given to the patient before induction.

Both groups will be induced with propofol 2 mg/kg and cisatracurium 0.15 mg/kg to facilitate endotracheal intubation and maintained with inhaled isoflurane and incremental doses of muscle relaxant if needed. Neuromuscular blockade will be reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg.

In both groups intraoperative monitoring of heart rate (beats/min) and mean arterial blood pressure (mmHg) will be documented.

Postoperatively:

In the recovery room and in the surgical ward the patient's mean blood pressure and heart rate will be measured and recorded at 1, 2, 4, 6, and 12 hours postoperatively. Also, the postoperative pain assessment for all patients will be done by an anesthesiologist (independent observer) at 1, 2, 4, 6 and 12 hours after surgery based on the visual analog scale (VAS) (a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border). The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. A Quality of Recovery questionnaire (QoR-40) will be administered 24 hours postoperatively by an anaesthesiologist independent of the anaesthetic team and not involved in drug administration.

Rescue analgesia (intravenous Ketorolac 30 mg) was administered if tachycardia and/or hypertension occurred postoperatively, defined as an increase in heart rate or blood pressure of more than 25 % from baseline, or if the VAS score was 5 or higher. Time to first request for postoperatiev rescue analgesia will be recorded.

Rescue antiemetics (Ondansetron 8 mg) will be given to any patient complaining of nausea and vomiting, occurrence of other side effects including bradycardia or hypotension will be recorded and managed (hypotension defined as a decrease in mean arterial pressure (MAP) of more than 20% of baseline value and planned to be treated with crystalloid infusion and 5 mg bolus of ephedrine. Bradycardia, defined as a heart rate below 50 beats/min, will be managed with atropine 0.2-0.5 mg. Patient satisfaction, postoperative sedation/agitation using the Richmod Agitation-Sedation Scale (RASS), and length of postoperative hospital stay will also be recorded.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Sharquia
    • Zagazig, Sharquia, Egypt, 7120730
      • Zagazig University , Fuculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

patients scheduled for a day case surgeries

Description

Inclusion Criteria:

• Patients scheduled for day case surgeries.
• Patient's age: 21-65 years.
• Patients with ASA physical status I, II.
• BMI 25 - 30 25-30 kg/m²

Exclusion Criteria:

• Uncooperative patients
• Patients with psychological problems
• Patients with liver or renal impairment
• Patients with a history of allergy to the drugs used in the study
• Patients with chronic pain and current use of analgesic therapy for a pre-existing condition
• Patients who did not fulfill the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paracetamol plus tramadol; Patients in Group T received an intravenous infusion of paracetamol (15 mg/kg) with tramadol (1 mg/kg), completed immediately before induction of anaesthesia.	Drug: tramadol plus paracetamol; Patients in Group T received an intravenous infusion of paracetamol (15 mg/kg) with tramadol (1 mg/kg), completed immediately before induction of anaesthesia.; Other Names: tramadol
Active Comparator: Fentanyl; Group F received a single intravenous injection of fentanyl 1.5 µg/kg before induction.	Drug: Fentanyl Injection; Group F received a single intravenous injection of fentanyl 1.5 µg/kg before induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enhanced Recovery Score	It will be derived from the 40-item Quality of Recovery questionnaire (QoR-40), which assesses five dimensions of postoperative recovery: emotional state, physical comfort, psychological support, physical independence and pain. Each of the 40 items is scored from 1 (worst) to 5 (best), yielding a total score ranging from 40 to 200.	The QoR-40 was administered 24 hours after the surgery by an anaesthesiologist independent of the anaesthetic team and not involved in drug administration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity	It will be assessed using the 10 cm visual analogue scale (VAS; 0 = no pain, 10 = worst pain imaginable) and the patient was instructed to mark along the line which pain intensity is currently being experienced.	On arrival to the recovery room and at 1, 2, 4, 6, and 12 hours postoperatively.
Rescue analgesic	Document the first time for the need of rescue analgesia.	From arrival to the recovery room until the first request for rescue analgesia, assessed up to 24 hours postoperatively.
Postoperative sedation/agitation	Will be assessed using the Richmond Agitation-Sedation Scale (RASS).	After extubation, on arrival to the recovery room and at 10 and 20 minutes after arrival to the recovery room.
Mean arterial blood pressure	Compare mean arterial blood pressure (mmHg) between patients in both groups.	Baseline (preoperatively) and on arrival to the recovery room postoperatively.
Heart Rate	Compare the heart rate (beats/min) between patients in both groups.	Baseline (preoperatively) and on arrival to the recovery room postoperatively.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Document the incidence of adverse events including bradycardia, hypotension, nausea, and vomiting.	Up to twenty-four hours after surgery
Length of hospital stay	Compare the length of hospital stay in both groups.	Up to twenty-four hours after surgery.

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: MICHAEL A shaker, lecturer, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: July 29, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Fentanyl; Paracetamol; Enhanced recovery after surgery; Tramadol; Pre-emptive analgesia; Day-case surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lipids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Piperidines; Alcohols; Cyclohexanols; Hexanols; Fatty Alcohols; Dimethylamines; Methylamines; Acetaminophen; Fentanyl; Tramadol
• Other Study ID Numbers: ZU-IRB 459 /14-July 2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No