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Could a pill replace a needle for emergency pain relief?

NCT ID NCT01586143

Symptom relief Sponsor: University Hospital, Clermont-Ferrand 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether a 125 mg paracetamol tablet that dissolves in the mouth can relieve acute pain as effectively as a 1 g intravenous (IV) infusion. Adults aged 18 to 60 with moderate pain from minor limb injuries in the emergency room will be randomly assigned to one of the two treatments. Pain levels will be tracked using a visual analogue scale at several time points after dosing to compare the two approaches.

What this could mean

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

Active substance
paracetamol
What this could lead to
If effective, a mouth-dissolving paracetamol tablet could offer a simpler, less invasive way to manage acute pain in emergency settings, potentially reducing the need for IV lines.
What could go wrong
This is a small Phase 3 trial, and the mouth-dissolving tablet may not work as quickly or as strongly as the IV form. Results may not apply to all types of pain or patients.

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

43 people

The number who actually took part.

Start date

May 2012

Finished

May 2013

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 to 60 years

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: * Patient admitted to emergency departments with trauma of upper or lower limbs (sprains, muscle contusions,…) associated with intensity moderate of acute pain (VAS between 4 and 6) which require infusion IV of paracetamol 1g. * Patient takes any chronic treatment which considered incompatible with study. * Patient between 18 and 60. * Male or female. * Sufficient cooperation and understanding to comply to the requirements of study. * Acceptance to give a written consent. * Affiliation at system of French social security. * Inscription or acceptation of inscription at national register of voluntaries participant at research Exclusion Criteria: * Against paracetamol-indication: hypersensitivity known at paracétamol, antecedent hepatitis B or C, severe renal insufficiency and liver failure. * Patient with medical or surgical antecedents. * Patient with progressive disease at balance of inclusion. * Alcoholism suspicion or toxicomany at intake. * Patient who presents any inflammation or ulcerative pathology about buccal mucosa. * Patient who refuses to ingest alcohol for personal reasons. * Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman. * Patient who participated in another clinical trial, located in exclusion period or received benefits \> 4500 euros during 12 months before the beginning of trial. * Patient with cooperation and understanding insufficiency to comply to the requirements of protocol * Patient with social protection * No affiliation at system of French social security

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Conditions

The condition(s) this trial relates to.

Acute Pain Pain Sprains and Strains

As listed by the trial registrant

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

Acute pain

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

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