Paracetamol Plus Tramadol Versus Fentanyl in Day Case Surgeries

NCT05990686 | Completed Phase 4

• 1 other identifier: ZU-IRB 459 /14-July 2024
• Study Type: interventional
• Target: 102
• 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 the effect of preemptive use of paracetamol plus tramadol versus preemptive intravenous fentanyl in controlling postoperative pain

Conditions

Preemptive Analgesia; Post Operative Pain

Keywords

Tramadol; Fentanyl; Paracetamol; Pre-emptive analgesia; Enhanced recovery after surgery; Day-case surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative pain intensity

  On arrival to the recovery room and at 1, 2, 4, 6, and 12 hours postoperatively.

• Rescue analgesic

  From arrival to the recovery room until the first request for rescue analgesia, assessed up to 24 hours postoperatively.

• Postoperative sedation/agitation

  After extubation, on arrival to the recovery room and at 10 and 20 minutes after arrival to the recovery room.

• Mean arterial blood pressure

  Baseline (preoperatively) and on arrival to the recovery room postoperatively.

• Heart Rate

  Baseline (preoperatively) and on arrival to the recovery room postoperatively.

Other Outcomes (2)

• Adverse events

  Up to twenty-four hours after surgery

• Length of hospital stay

  Up to twenty-four hours after surgery.

Study Arms (2)

Paracetamol plus tramadol

ACTIVE COMPARATOR

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

Fentanyl

ACTIVE COMPARATOR

Group F received a single intravenous injection of fentanyl 1.5 µg/kg before induction.

Drug: Fentanyl Injection

Interventions

Fentanyl Injection DRUG

Group F received a single intravenous injection of fentanyl 1.5 µg/kg before induction.

Fentanyl

tramadol plus paracetamol DRUG

Patients in Group T received an intravenous infusion of paracetamol (15 mg/kg) with tramadol (1 mg/kg), completed immediately before induction of anaesthesia.

Also known as: tramadol

Paracetamol plus tramadol

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University , Fuculty of Medicine

Zagazig, Sharquia, 7120730, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol; Acetaminophen; 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; Acetanilides; Anilides; Amides; Aniline Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• MICHAEL A shaker, lecturer

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients were blinded to their allocated group. The anaesthesiologist who assessed postoperative VAS and sedation scores and who administered rescue analgesia, antiemetics, or treatment for hypotension and bradycardia was also blinded to group allocation. Only the anaesthetic team in the operating theatre, who administered the study drugs and general anaesthesia, was aware of the allocated group, owing to differences in the volume and appearance of the two regimens.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• 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: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

EG (1)