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New painkiller could cut opioid use in ICU patients

NCT ID NCT05071352

Symptom relief Sponsor: Cairo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a continuous infusion of nefopam, a non-opioid painkiller, can reduce the need for fentanyl (a strong opioid) in critically ill patients on mechanical ventilators. Sixty adults were randomly assigned to receive either nefopam plus standard care or standard care alone. The goal was to see if nefopam could provide effective pain relief while lowering opioid doses and their side effects.

What this could mean

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

Active substance
Nefopam (a non-opioid painkiller)
What this could lead to
If it works, this could offer a way to reduce opioid use in ICU patients on ventilators, potentially lowering side effects like addiction or breathing problems.
What could go wrong
This is a small, single-center trial with only 60 patients, so results may not apply broadly. Nefopam may not reduce opioid use as hoped, and side effects like nausea or sweating are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

60 people

The number who actually took part.

Started

Oct 2021

Finished

Mar 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Adult patients \>18 years on mechanical ventilation and expected to need ventilatory support for the next 24 hours. 2. Candidate for sedation and analgesia protocol Exclusion Criteria: 1. Pregnant and/or lactating woman. 2. Has been intubated for duration longer than 12 hours in an intensive care unit. 3. Proven or suspected acute primary brain lesion such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury. 4. Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness. 5. Admission as a consequence of a suspected or proven drug overdose 6. Mean arterial pressure (MAP) \< 50 mmHg despite adequate resuscitation and vasopressor therapy at time of randomization. 7. Death is deemed to be imminent or inevitable during this admission and either the attending physician, patient or substitute decision maker is not committed to active treatment. 8. Patients with severe hepatic impairment (Child-Pugh class C) or end stage renal disease (ESRD) (creatinine clearance \< 30 ml/min or on chronic hemodialysis) due to altered pharmacokinetics \[20\]. 9. Need for deep sedation such as administration of neuromuscular blockers. 10. Convulsions or previous history of convulsions. 11. Risk of urinary retention linked to uretroprostatic disorders. 12. Risk of acute angle glaucoma. 13. Known intolerance of or hypersensitivity to study medications or constituents.

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Conditions

The condition(s) this trial relates to.

agnosia Critical Illness delirium pain agnosia

As listed by the trial registrant

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

Analgesia Critical illness Mechanical ventilation Sedation

Contacts and locations

Locations

  • Cairo University Hospitals (Kasr Alainy)

    Cairo, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.