CHRU De Nancy
Verified site
Vandoeuvre Les Nancy, France
Not yet recruiting
Efficacy of sublingual sufentanil versus oral morphine sulfate for acute postoperative pain in adult surgical patients: a randomized controlled trial
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The study looks at people who have had surgery and are dealing with postoperative pain. After the operation, a strong pain medicine called sufentanil is given as a small tablet that dissolves under the tongue (sublingual), while another group receives a standard oral tablet of morphine sulfate. The purpose of the study is to find out whether the sublingual form of the medication helps patients recover faster and feel better three days after surgery compared with the usual oral medicine.
Participants will receive one of the two medicines when they need extra pain relief after surgery and will be asked to fill out a short survey called the QoR-15F on the third day to rate how they feel. Researchers will also watch for common side effects of strong pain medicines, such as nausea, sleepiness, or breathing problems, and will check whether any pain medicine is still being used two weeks later, sometimes by a phone call. A small number of participants will have a simple test called QST to see how their skin senses pain, but this does not involve any special equipment. The overall follow‑up period lasts about two weeks, with most visits happening while the patient is still in the hospital.
The research process
The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Age: You must be 18 years old or older. There is no upper age limit.
- Recent surgery: You must have had an operation in a hospital surgery department where the usual care after surgery includes a prescription for an oral rescue opioid (a pain‑relieving medicine taken by mouth that can be used if needed).
- Informed consent: You must be able to understand the study information and voluntarily agree to take part.
- Social security health coverage: You must be enrolled in or receive benefits from a social security health insurance plan.
- Women of childbearing potential: If you are a woman who could become pregnant, you must have a negative blood pregnancy test at the screening visit and must use a highly effective birth‑control method (such as an IUD, implant, sterilization, or consistent use of hormonal or barrier methods) until four days after the last dose of the study medication Dzuvéo.
Who cannot join the trial?
15 criteria
- Allergy (hypersensitivity) to the study medicines Dzuveo® or Actiskénan® – you cannot participate if you are known to be allergic to any ingredient in these drugs.
- Serious head injury with high pressure inside the skull (intracranial hypertension) in the acute phase – recent severe head trauma with swelling that raises brain pressure excludes you.
- Uncontrolled epilepsy – if you have a seizure disorder that is not well‑controlled, you cannot join the trial.
- Ileus or other delayed stomach emptying – a condition where the intestines do not move food normally prevents participation.
- Use of strong CYP3A4‑inhibiting medicines (e.g., ketoconazole, clarithromycin, ritonavir, etc.) at the time of randomisation, stopped less than 7 days ago, or planned to start during the study; these drugs affect how the trial medication is processed.
- Use of strong CYP3A4‑inducing medicines (e.g., rifampicin, carbamazepine, St. John’s wort, etc.) at the time of randomisation, stopped less than 3 weeks ago, or planned to start during the study; these drugs also change the way the trial medication works.
- Use of monoamine oxidase inhibitors (MAOIs) or having stopped them within the past 2 weeks (examples: marsilid, moclobemide). MAOIs are a type of antidepressant that can interact dangerously with the study drug.
- Pregnant or breastfeeding women – you cannot take part if you are currently pregnant or nursing a baby.
- Regular use of strong pain medicines (opioids) before surgery – daily use of drugs such as morphine, fentanyl, oxycodone, buprenorphine, methadone, etc., makes you ineligible.
- History of drug, medication, or alcohol dependence or abuse – any past or present problem with illegal drugs, misused medicines, or alcohol excludes you.
- Legal protection status (vulnerable subjects) – people under guardianship, curatorship, tutorship, or other court‑ordered protection cannot be enrolled.
- Inability to complete the required questionnaire because of cognitive problems, language barriers, emergency situations, or difficulty understanding the study information.
- Severe breathing problems such as decompensated respiratory failure, known respiratory depression, severe asthma, or severe chronic obstructive pulmonary disease (COPD) make you ineligible.
- Severe liver failure (hepatocellular insufficiency) with encephalopathy – advanced liver disease that affects brain function excludes you.
- Severe kidney impairment (glomerular filtration rate < 30 ml/min) – poor kidney function prevents participation.
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Verified sites
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Institut De Cancerologie De Lorraine
Verified siteVandoeuvre Les Nancy, FranceCentre Hospitalier Universitaire Reims
Verified siteReims, France
Trial locations
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Investigated drugs
sufentanil
is a strong pain‑relieving medicine that is placed under the tongue as a tablet. In this study it is given as a rescue medication when a patient’s pain after surgery is not controlled by the regular pain plan. Because it works quickly through the tissues under the tongue, it can provide fast relief of acute postoperative pain.
morphine
is a well‑known opioid pain medication that is taken by mouth as a dissolving tablet. In the trial it is used as the active comparison to see how well the sublingual sufentanil works. Patients can take it when they need extra pain relief after surgery, following the standard multimodal pain‑management approach.
What is already known about the treatment
Dzuveo 30 micrograms sublingual tablet
This medication comes as a small tablet that is placed under the tongue, where it dissolves and is absorbed quickly. It is an approved drug used for rescue pain relief after surgery and is well described in medical literature. It is given to patients who need fast relief from moderate to severe postoperative pain. It works by binding to opioid receptors in the brain, which lowers the feeling of pain, and it belongs to the class of synthetic opioid analgesics.
ACTISKENAN 10 mg, comprimé orodispersible
This drug is an orodispersible tablet that is placed in the mouth, where it melts and can be swallowed without water. It is a widely used form of oral morphine that has been on the market for many years for treating acute pain after surgery. It is prescribed when a patient needs additional pain control beyond the regular regimen. It relieves pain by attaching to the same opioid receptors in the brain, reducing pain signals, and it is classified as a natural opiate analgesic.
Investigated diseases
Postoperative pain - Postoperative pain is the discomfort that arises after a surgical procedure. It typically begins shortly after the operation and may last from a few hours to several days. The intensity can vary depending on the type and extent of surgery. Pain often follows a pattern of peaks during movement and subsides with rest. As healing progresses, the pain usually diminishes.
Trial detailsLast updated 5 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-527137-64-00Protocol codeRC26_0234Estimated enrolment1 150 patientsSponsorLes Hopitaux Universitaires De Strasbourg
sourced from the EU Clinical Trials Register and site verification
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