Acute Pain Due to TraumaPhase 3NCT03222518
NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management
A Phase 3 study testing Paracetamol, NSAID and paracetamol-NSAID 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 NSAIDs alone against the association of paracetamol + NSAIDs in the treatment of traumatic pain. 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, NSAID and paracetamol-NSAID
- 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 Mar 2017to 1 Nov 2018
- 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
- acute (<24 hours) post traumatic pain of the extremity and requiring analgesic treatment upon discharge for pain with intensity >3 on a visual numeric scale
Who cannot join
- open fracture
- head, abdominal, thoracic or polytrauma.
- Need for hospitalization, regular use of paracetamol and NSAIDs during the two weeks before admission to ED
- history of allergy or hypersensitivity to either paracetamol or NSAIDs,
- contraindication to paracetamol or NSAIDs,
- acute /history of GI hemorrhage and renal insufficiency,
Show all 13Show fewer
- an inability to assess pain intensity according to the VNS.
- Pregnancy
- heart failure
- known hepatic cirrhosis
- known severe renal impairment (Creatinine clearance <30 ml/min)
- swallowing disorders
- Refusal, incapacity or difficulties to consent or to communicate
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to:
Compare the effect of paracetamol alone against NSAIDs alone against the association of paracetamol + NSAIDs in the treatment of traumatic pain.
Read the detailed description
Paracetamol, NSAIDs, or a combination of the two molecules are usually prescribed. Patients even use these medications without a prescription. It is not known, however, whether or not NSAIDs have an additional value relative to paracetamol for the treatment of pain.
All patients were assigned in a 1:1:1 ratio. Randomization of subjects was performed centrally according to a computer-generated random code provided by one of investigators who was not involved in any other part of the trial. The patients included were divided into 3 groups: Paracetamol group who received paracetamol 1000 mg orally every 8th hour for 7 days; NSAID group who received piroxicam 20 mg orally twice a day for 7 days, and Paracetamol-NSAID combination who received both treatments at the same doses for 7 days. All protocol treatments were administered in opaque packets with code number according to the randomization list by an independent nurse who was not involved in monitoring or follow-up of the individuals. Data were collected for each patient, including demographics, medical history, and findings of the clinical examination. Injury Severity Score (ISS) whose values range from 0 to 75 was also assessed. Each patient was re-evaluated on the 3rd and 7th day post-trauma (D7) using a telephone contact by a clinical research associates who was blinded to the details of the study to note the following clinical data: pain VNS, ED readmissions for residual pain, need for other analgesics other than those of the protocol, other treatment modalities the patient might have used (adherence to the treatment prescribed), and side effects. In addition patients were asked about their satisfaction with pain control following ED using five point Likert scale: very dissatisfied, not satisfied, neutral, satisfied and very satisfied and about the degree to which they adhered to medication schedule. The principal investigator who was aware of the allocation was not involved in monitoring or recording of the outcomes until the data collection was completed.
- Conditions
- Acute Pain Due to Trauma
- Being tested
- Paracetamol, NSAID, paracetamol-NSAID
- Keywords
- acute pain, trauma, paracetamol, NSAID
- 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
21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period
NSAIDDrug
Also called piroxicam
14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period
paracetamol-NSAIDDrug
Also called combination
21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period
| Study group | Role | What they receive |
|---|---|---|
| Parcetamol Group | Active comparator | The patient receives an envelope containing Paracetamol 1000 mg at the dose of 3 times / day + follow-up sheet + appointment card. Receives: Drug: NSAID; Drug: paracetamol-NSAID |
| NSAID Group | Active comparator | The patient receives an envelope containing NSAID 20 mg piroxicam twice daily / day + follow-up sheet + appointment card. Receives: Drug: Paracetamol; Drug: paracetamol-NSAID |
| NSAID + Paracetamol Group | Active comparator | The patient receives an envelope containing NSAID 20 mg piroxicam at a dose of 2 times/day + Paracetamol 1000 mg at a dose of 3 times / day + follow-up sheet + appointment card. Receives: Drug: Paracetamol; Drug: NSAID |
What is being measured
The primary outcome is the main question the study is designed to answer.
new oral analgesic medications needed rate
oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition
Measured: 3 days and 7 days
Secondary outcomes (4)
the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later
[delta VNS= (VNS D0 - VNS D7 / VNS D0) x 100]
Measured: 3 and 7 days
The appearance of side effects
The appearance of side effects: such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness.
- Digestive hemorrhage.
Measured: 7 days
the rate of ED readmissions for residual pain
ED readmissions for residual pain
Measured: 3 and 7 days
patient satisfaction assessed by Likert's verbal scale.
patient satisfaction assessed by Likert's verbal scale.
Measured: 3 and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Mar 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
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
- Model description
- Subjects are randomized in 3 arms: * paracetamol group * NSAID group * paracetamol + NSAID group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- 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
- Semir Nouira, MD, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222518
- Sponsor's protocol ID
- PAR vs NSAIDs vs Comb in Pain
- Status last verified
- Sep 2020
- First submitted
- 14 May 2017
- Last updated
- 30 Sep 2020
- 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 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management
- ClinicalTrials.gov ID
- NCT03222518
- Acronym / sponsor ID
- PAR vs NSAIDs vs Comb in Pain
- Conditions
- Acute Pain Due to Trauma
- Keywords
- acute pain, trauma, paracetamol, NSAID
- 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 Mar 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 19 Jul 2017 (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 NSAIDs alone against the association of paracetamol + NSAIDs in the treatment of traumatic pain.
Detailed description
Paracetamol, NSAIDs, or a combination of the two molecules are usually prescribed. Patients even use these medications without a prescription. It is not known, however, whether or not NSAIDs have an additional value relative to paracetamol for the treatment of pain.
All patients were assigned in a 1:1:1 ratio. Randomization of subjects was performed centrally according to a computer-generated random code provided by one of investigators who was not involved in any other part of the trial. The patients included were divided into 3 groups: Paracetamol group who received paracetamol 1000 mg orally every 8th hour for 7 days; NSAID group who received piroxicam 20 mg orally twice a day for 7 days, and Paracetamol-NSAID combination who received both treatments at the same doses for 7 days. All protocol treatments were administered in opaque packets with code number according to the randomization list by an independent nurse who was not involved in monitoring or follow-up of the individuals. Data were collected for each patient, including demographics, medical history, and findings of the clinical examination. Injury Severity Score (ISS) whose values range from 0 to 75 was also assessed. Each patient was re-evaluated on the 3rd and 7th day post-trauma (D7) using a telephone contact by a clinical research associates who was blinded to the details of the study to note the following clinical data: pain VNS, ED readmissions for residual pain, need for other analgesics other than those of the protocol, other treatment modalities the patient might have used (adherence to the treatment prescribed), and side effects. In addition patients were asked about their satisfaction with pain control following ED using five point Likert scale: very dissatisfied, not satisfied, neutral, satisfied and very satisfied and about the degree to which they adhered to medication schedule. The principal investigator who was aware of the allocation was not involved in monitoring or recording of the outcomes until the data collection was completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects are randomized in 3 arms: * paracetamol group * NSAID group * paracetamol + NSAID group
| Arm | Type | Receives |
|---|---|---|
| Parcetamol Group | Active comparator | Drug: NSAID, Drug: paracetamol-NSAIDThe patient receives an envelope containing Paracetamol 1000 mg at the dose of 3 times / day + follow-up sheet + appointment card. |
| NSAID Group | Active comparator | Drug: Paracetamol, Drug: paracetamol-NSAIDThe patient receives an envelope containing NSAID 20 mg piroxicam twice daily / day + follow-up sheet + appointment card. |
| NSAID + Paracetamol Group | Active comparator | Drug: Paracetamol, Drug: NSAIDThe patient receives an envelope containing NSAID 20 mg piroxicam at a dose of 2 times/day + Paracetamol 1000 mg at a dose of 3 times / day + follow-up sheet + appointment card. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 years or older
- acute (<24 hours) post traumatic pain of the extremity and requiring analgesic treatment upon discharge for pain with intensity >3 on a visual numeric scale
Key exclusion criteria (13 listed)
- open fracture
- head, abdominal, thoracic or polytrauma.
- Need for hospitalization, regular use of paracetamol and NSAIDs during the two weeks before admission to ED
- history of allergy or hypersensitivity to either paracetamol or NSAIDs,
- contraindication to paracetamol or NSAIDs,
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 |
|---|---|---|
| Paracetamol21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period | Drug | NSAID + Paracetamol Group, NSAID Group |
| NSAIDAlso: piroxicam14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period | Drug | NSAID + Paracetamol Group, Parcetamol Group |
| paracetamol-NSAIDAlso: combination21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period | Drug | NSAID Group, Parcetamol Group |
Primary outcome
new oral analgesic medications needed rate
Time frame: 3 days and 7 days
oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition
4 secondary outcomes
the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later
Time frame: 3 and 7 days
The appearance of side effects
Time frame: 7 days
the rate of ED readmissions for residual pain
Time frame: 3 and 7 days
patient satisfaction assessed by Likert's verbal scale.
Time frame: 3 and 7 days
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 30 Sep 2020.
- 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.
Semir Nouira, MD principal investigator
University of Monastir
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, NSAID and paracetamol-NSAID 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 2 inclusion and 13 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 30 Sep 2020. 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?
new oral analgesic medications needed rate (time frame: 3 days and 7 days). 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 30 Sep 2020.