Acute Pain Due to TraumaPhase 3NCT05229965
Paracetamol Vs Caffeine Vs Codeine in the Management of Post Traumatic Pain in Emergencies
A Phase 3 study testing Paracetamol, Paracetamol Codeine and Paracetamol caféine in people with Acute Pain Due to Trauma, run by University of Monastir at 1 site in Tunisia.
Trial summary
The purpose of this study is to: Compare the effect of paracetamol alone against Paracetamol+Codeine association against the association of paracetamol + Cafeine in the treatment of post-traumatic acute pain of the limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain Due to Trauma
- What is being tested?
- Paracetamol, Paracetamol Codeine and Paracetamol caféine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Nov 2022to 27 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age :18 years or older
- Patients presented to the emergency department with acute post-traumatic pain and residual pain at rest and/or on movement with a numerical pain rating scale (NRS) > 3/10 on discharge.
- They all signed a written consent form.
Who cannot join
- Self-mutilation
- Severe acute trauma that may require hospitalization
- Open or complicated fracture requiring surgical management
- Regular use of analgesics
- Any known allergy to paracetamol, caffeine or codeine
- Asthma and acute/chronic respiratory insufficiency
Show all 10Show fewer
- Severe renal insufficiency (creatinine Cl<30 ml/min)
- Pregnant/lactating women
- Hepatic cirrhosis.
- Refusal, incapacity or difficulties to consent or to communicate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paracetamol Vs Paracetamol-Caffeine Association Vs Paracetamol-Codeine Association in the Management of Post Traumatic Pain in Emergencies
The purpose of this study is to:
Compare the effect of paracetamol alone against Paracetamol+Codeine association against the association of paracetamol + Cafeine in the treatment of post-traumatic acute pain of the limbs.
Read the detailed description
At admission to the emergency department, patients with acute post-traumatic pain will be included, regardless of their initial NRS .These patients will receive the necessary care for their injury (icing, reduction, immobilization, local care, sutures), then went home with a medical prescription and an outpatient appointment .
At discharge and after obtaining their signed consent . All patients included will be randomized according to a numerical randomization table ( assigned in a 1:1:1 ratio) into 3 groups ( As a treatment for their post traumatic pain at discharge for 7 days ) :
- Group 1: Paracetamol group who will receive paracetamol ( 1000 mg) : one pill 3 times a day for 7 days .
- Group 2: Paracetamol-codeine group who will receive an association of 500 mg of Paracetamol and 30 mg of codeine : one pill twice a day for 7 days .
- Group 3: Paracetamol-cafeine group who will receive an association of 500 mg of Paracetamol and 65 mg of cafeine : one pill 3 times a day for 7 days .
For all patients included in the study, demographic and clinical data will be collected by the physician or investigator and recorded on a pre-established form.
The demographic data recorded on each patient's chart were as follows: Age, sex, origin and personal pathological history:
- Hypertension.
- Diabetes.
- Respiratory insufficiency.
- Renal insufficiency.
- Liver failure.
- Allergy.
And a Clinical examination data:
- Pain intensity (NRS).
- Mechanism of trauma and site of injury.
- Other physical examination data: systolic blood pressure (SBP), heart rate (HR) and temperature.
- Nature of traumatic injury.
- Final diagnosis
- Injury Severity Score (ISS).
- NRS at discharge (at rest and on movement).
Patients included will be assessed at Day 1 , Day 2 , Day 3 and Day 7 after discharge from the emergency department by a telephone call. This evaluation will include :
- NRS at rest and during movement
- Secondary use of another analgesic.
- Patient satisfaction assessed by Likert scale, with 3 responses:
- Satisfied
- Moderately satisfied
- Not satisfied
- Side effects: epigastralgia, dizziness, somnolence, headache, nausea and/or vomiting, insomnia, constipation, palpitation, etc.
- Conditions
- Acute Pain Due to Trauma
- Being tested
- Paracetamol, Paracetamol Codeine, Paracetamol caféine
- Keywords
- acute pain, trauma, paracetamol, codeine, cafeine
- Medical subject headings
- Acute Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called 1000mg
21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period
Paracetamol CodeineDrug
Also called 500mg/ 30mg
14 pills will be provided with a preconised dose of 1 pill 2 times per day over 7 days period
Paracetamol caféineDrug
Also called 500mg/ 65mg
21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period
| Study group | Role | What they receive |
|---|---|---|
| Paracétamol Group | Active comparator | In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracétamol Caféine Group) .
In Paracetamol group , the patients will receive a pill containing 1000 mg of paracetamol 3 times a day for 7 days .
Paracétamol 1000 mg : 1 pill *3 / day Receives: Drug: Paracetamol |
| Paracétamol Codéine Group | Active comparator | In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) .
In Paracetamol codéine group , the patients will receive a pill containing an association of paracetamol and codéine ( 500mg / 30mg ) 3 times a day for 7 days .
-Association of Paracétamol and Codéine ( 500mg / 30 mg) : 1 pill *2 /day Receives: Drug: Paracetamol Codeine |
| Paracétamol Caféine Group | Active comparator | In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) .
In Paracetamol caféine group , the patients will receive a pill containing an association of paracetamol and caféine ( 500mg / 65 mg ) 3 times a day for 7 days .
-Association of Paracétamol and Caféine ( 500mg / 65 mg) : 1 pill *3 /day Receives: Drug: Paracetamol caféine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta Numerical Rating Scale (NRS) ( From 0 to 10 )
Treatment success is defined by the percentage of patients with a reduction in movement NRS at Day 7 discharge (Delta NRS ) ≥ 50% compared with NRS at emergency discharge. ( that mean a better outcome )
Delta NRS ( in movement)=(NRS (at discharge )-NRS (day7))/(NRS (at discharge )) X 100 .
Measured: 7 days from discharge
Secondary outcomes (3)
Appearance of side effects
The appearance of side effects such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness and Digestive hemorrhage.
Measured: 7 days from discharge
Need for another analgesic medication or non-pharmacological analgesic intervention
The patient's need to add another analgesic medication or non-pharmacological analgesic intervention
Measured: 7 days from discharge
Patient satisfaction assessed by Likert's verbal scale at 7 days
patient satisfaction assessed by Likert's verbal scale : with 3 responses:
- Satisfied
- Moderately satisfied
- Not satisfied
Measured: 7 days from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Nov 2022
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pain Due to TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Semir, Principal investigator, Monastir University Hospital, Monastir, Tunisia, 5000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229965
- Sponsor's protocol ID
- Codeine-Cafeine-Paracetamol
- Status last verified
- Jun 2023
- First submitted
- 8 Dec 2021
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol Vs Paracetamol-Caffeine Association Vs Paracetamol-Codeine Association in the Management of Post Traumatic Pain in Emergencies
- ClinicalTrials.gov ID
- NCT05229965
- Acronym / sponsor ID
- Codeine-Cafeine-Paracetamol
- Conditions
- Acute Pain Due to Trauma
- Keywords
- acute pain, trauma, paracetamol, codeine, cafeine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to:
Compare the effect of paracetamol alone against Paracetamol+Codeine association against the association of paracetamol + Cafeine in the treatment of post-traumatic acute pain of the limbs.
Detailed description
At admission to the emergency department, patients with acute post-traumatic pain will be included, regardless of their initial NRS .These patients will receive the necessary care for their injury (icing, reduction, immobilization, local care, sutures), then went home with a medical prescription and an outpatient appointment .
At discharge and after obtaining their signed consent . All patients included will be randomized according to a numerical randomization table ( assigned in a 1:1:1 ratio) into 3 groups ( As a treatment for their post traumatic pain at discharge for 7 days ) :
- Group 1: Paracetamol group who will receive paracetamol ( 1000 mg) : one pill 3 times a day for 7 days .
- Group 2: Paracetamol-codeine group who will receive an association of 500 mg of Paracetamol and 30 mg of codeine : one pill twice a day for 7 days .
- Group 3: Paracetamol-cafeine group who will receive an association of 500 mg of Paracetamol and 65 mg of cafeine : one pill 3 times a day for 7 days .
For all patients included in the study, demographic and clinical data will be collected by the physician or investigator and recorded on a pre-established form.
The demographic data recorded on each patient's chart were as follows: Age, sex, origin and personal pathological history:
- Hypertension.
- Diabetes.
- Respiratory insufficiency.
- Renal insufficiency.
- Liver failure.
- Allergy.
And a Clinical examination data:
- Pain intensity (NRS).
- Mechanism of trauma and site of injury.
- Other physical examination data: systolic blood pressure (SBP), heart rate (HR) and temperature.
- Nature of traumatic injury.
- Final diagnosis
- Injury Severity Score (ISS).
- NRS at discharge (at rest and on movement).
Patients included will be assessed at Day 1 , Day 2 , Day 3 and Day 7 after discharge from the emergency department by a telephone call. This evaluation will include :
- NRS at rest and during movement
- Secondary use of another analgesic.
- Patient satisfaction assessed by Likert scale, with 3 responses:
- Satisfied
- Moderately satisfied
- Not satisfied
- Side effects: epigastralgia, dizziness, somnolence, headache, nausea and/or vomiting, insomnia, constipation, palpitation, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paracétamol Group | Active comparator | Drug: ParacetamolIn each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracétamol Caféine Group) . In Paracetamol group , the patients will receive a pill containing 1000 mg of paracetamol 3 times a day for 7 days . Paracétamol 1000 mg : 1 pill *3 / day |
| Paracétamol Codéine Group | Active comparator | Drug: Paracetamol CodeineIn each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) . In Paracetamol codéine group , the patients will receive a pill containing an association of paracetamol and codéine ( 500mg / 30mg ) 3 times a day for 7 days . -Association of Paracétamol and Codéine ( 500mg / 30 mg) : 1 pill *2 /day |
| Paracétamol Caféine Group | Active comparator | Drug: Paracetamol caféineIn each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) . In Paracetamol caféine group , the patients will receive a pill containing an association of paracetamol and caféine ( 500mg / 65 mg ) 3 times a day for 7 days . -Association of Paracétamol and Caféine ( 500mg / 65 mg) : 1 pill *3 /day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age :18 years or older
- Patients presented to the emergency department with acute post-traumatic pain and residual pain at rest and/or on movement with a numerical pain rating scale (NRS) > 3/10 on discharge.
- They all signed a written consent form.
Key exclusion criteria (10 listed)
- Self-mutilation
- Severe acute trauma that may require hospitalization
- Open or complicated fracture requiring surgical management
- Regular use of analgesics
- Any known allergy to paracetamol, caffeine or codeine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: 1000mg21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period | Drug | Paracétamol Group |
| Paracetamol CodeineAlso: 500mg/ 30mg14 pills will be provided with a preconised dose of 1 pill 2 times per day over 7 days period | Drug | Paracétamol Codéine Group |
| Paracetamol caféineAlso: 500mg/ 65mg21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period | Drug | Paracétamol Caféine Group |
Primary outcome
Delta Numerical Rating Scale (NRS) ( From 0 to 10 )
Time frame: 7 days from discharge
Treatment success is defined by the percentage of patients with a reduction in movement NRS at Day 7 discharge (Delta NRS ) ≥ 50% compared with NRS at emergency discharge. ( that mean a better outcome ) Delta NRS ( in movement)=(NRS (at discharge )-NRS (day7))/(NRS (at discharge )) X 100 .
3 secondary outcomes
Appearance of side effects
Time frame: 7 days from discharge
Need for another analgesic medication or non-pharmacological analgesic intervention
Time frame: 7 days from discharge
Patient satisfaction assessed by Likert's verbal scale at 7 days
Time frame: 7 days from discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nouira Semir principal investigator
Monastir University Hospital, Monastir, Tunisia, 5000
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paracetamol, Paracetamol Codeine and Paracetamol caféine in people with Acute Pain Due to Trauma, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta Numerical Rating Scale (NRS) ( From 0 to 10 ) (time frame: 7 days from discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.