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Can a pre-surgery paracetamol and tramadol combo beat fentanyl for day-case pain?

NCT ID NCT05990686

Symptom relief Sponsor: Zagazig University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers compare two ways to prevent pain after day-case surgery: an intravenous mix of paracetamol and tramadol, or a single dose of fentanyl, both given before anaesthesia. The trial enrolls 102 adults aged 21 to 65 with a BMI of 25 to 30 who are scheduled for day-case operations. The main measure is a 40-item recovery questionnaire covering comfort, emotions, independence, support, and pain, with pain intensity and time to first rescue painkiller as secondary measures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
paracetamol plus tramadol
What this could lead to
If the combination works better, it could give day-surgery patients a pre-emptive pain option that reduces opioid reliance and supports faster discharge.
What could go wrong
This is a single-centre Phase 4 trial with 102 adults having day-case surgery, so results may not apply to other operations or patient groups. Tramadol can cause nausea, dizziness, and drowsiness, and fentanyl carries risks of breathing depression and sedation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

102 people

The number who actually took part.

Started

Jun 2025

Finished

Dec 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post operative pain Preemptive analgesia

Contacts and locations

Locations

  • Zagazig University , Fuculty of Medicine

    Zagazig, Sharquia, 7120730, Egypt

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