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Completed

NCT Number: NCT05990686

Paracetamol Plus Tramadol Versus Fentanyl in Day Case Surgeries

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

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zagazig University , Fuculty of Medicine

Zagazig, Sharquia, 7120730, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: tramadol

Fentanyl Injection

Drug

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

Primary outcomes

  1. Enhanced Recovery Score

    Time frame: The QoR-40 was administered 24 hours after the surgery by an anaesthesiologist independent of the anaesthetic team and not involved in drug administration.

    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.

Secondary outcomes

  1. Postoperative pain intensity

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

    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.

  2. Rescue analgesic

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

    Document the first time for the need of rescue analgesia.

  3. Postoperative sedation/agitation

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

    Will be assessed using the Richmond Agitation-Sedation Scale (RASS).

  4. Mean arterial blood pressure

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

    Compare mean arterial blood pressure (mmHg) between patients in both groups.

  5. Heart Rate

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

    Compare the heart rate (beats/min) between patients in both groups.

Other outcomes

  1. Adverse events

    Time frame: Up to twenty-four hours after surgery

    Document the incidence of adverse events including bradycardia, hypotension, nausea, and vomiting.

  2. Length of hospital stay

    Time frame: Up to twenty-four hours after surgery.

    Compare the length of hospital stay in both groups.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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