Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Inject… (NCT01586143) | Clinical Trial Compass
CompletedPhase 3
Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Injection 1g in Slow Infusion IV in Patients With Acute Pain
France43 participantsStarted 2012-05
Plain-language summary
This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.