Acute PainNCT03243006
Effect of Early Pain Management at Triage on Opioid Consumption
A study testing Paracetamol and Tramadol/Paracetamol combination in people with Acute Pain, run by University of Monastir.
Trial summary
introduction: Pain remains one of the most common reasons of emergency department admission. Opioids are overprescribed in emergency departments to treat severe pain. objective: assessing the impact of ealy pain pain management on the use of intravenous morphine and on patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Paracetamol and Tramadol/Paracetamol combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Sep 2016
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age
- a visual analog scale (VAS) equal to or higher than 30/100 ,
- having given consent to participation
- No contraindications to products used in the course of the study.
Who cannot join
- having a vital distress that does not allow an adequate assessment of the intensity of the pain
- an inability to assess pain intensity according to the VAS,
- swallowing disorders or inability , or a contraindication or an allergy to the treatments used.
About this study
Official title: Effect of Early Analgesic Treatment on Opioid Consumption
introduction: Pain remains one of the most common reasons of emergency department admission. Opioids are overprescribed in emergency departments to treat severe pain.
objective: assessing the impact of ealy pain pain management on the use of intravenous morphine and on patient satisfaction.
- Conditions
- Acute Pain
- Being tested
- Paracetamol, Tramadol/Paracetamol combination, Placebo Oral Tablet
- Keywords
- acute pain, emergency department, opioid consumption
- Medical subject headings
- Acute Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
2 tablets of 500mg of paracetamol
Tramadol/Paracetamol combinationDrug
2 tablets of tramadol/paracetamol combination (32.5mg/325mg)
Placebo Oral TabletDrug
2 tablets of placebo
| Study group | Role | What they receive |
|---|---|---|
| group Placebo | Placebo comparator | Patients in this group (Placebo Oral Tablet) received two placebo tablets Receives: Drug: Placebo Oral Tablet |
| group Paracetamol | Active comparator | Patients in this group received two 500 mg paracetamol tablets Receives: Drug: Paracetamol |
| group Tramadol/Paracetamol combination | Active comparator | Patients in this group (Tramadol/Paracetamol combination ) received 2 tablets of Tramadol/Paracetamol combination (37.5mg/325mg) Receives: Drug: Tramadol/Paracetamol combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
use of rescue opioids
decreased consumption of intravenous morphine
Measured: DURING emergency department stay
Secondary outcomes (3)
patient satisfaction
patient satisfaction regarding the overall management in the emergency department measured by likert scale
Measured: When quitting emergency department
Length of emergency department stay
Measured: Until emergency department discharge
Pain intensity at emergency department discharge
Percentage of patients with visual analog scale <30
Measured: At emergency department discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Jan 2016
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies 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 N/A
- Primary purpose
- Supportive care
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243006
- Sponsor's protocol ID
- Triage treatment
- Status last verified
- Nov 2017
- First submitted
- 15 Jul 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Analgesic Treatment on Opioid Consumption
- ClinicalTrials.gov ID
- NCT03243006
- Acronym / sponsor ID
- Triage treatment
- Conditions
- Acute Pain
- Keywords
- acute pain, emergency department, opioid consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 8 Aug 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.
introduction: Pain remains one of the most common reasons of emergency department admission. Opioids are overprescribed in emergency departments to treat severe pain.
objective: assessing the impact of ealy pain pain management on the use of intravenous morphine and on patient satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group Placebo | Placebo comparator | Drug: Placebo Oral TabletPatients in this group (Placebo Oral Tablet) received two placebo tablets |
| group Paracetamol | Active comparator | Drug: ParacetamolPatients in this group received two 500 mg paracetamol tablets |
| group Tramadol/Paracetamol combination | Active comparator | Drug: Tramadol/Paracetamol combinationPatients in this group (Tramadol/Paracetamol combination ) received 2 tablets of Tramadol/Paracetamol combination (37.5mg/325mg) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 18 years of age
- a visual analog scale (VAS) equal to or higher than 30/100 ,
- having given consent to participation
- No contraindications to products used in the course of the study.
Key exclusion criteria (3 listed)
- having a vital distress that does not allow an adequate assessment of the intensity of the pain
- an inability to assess pain intensity according to the VAS,
- swallowing disorders or inability , or a contraindication or an allergy to the treatments used.
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 |
|---|---|---|
| Paracetamol2 tablets of 500mg of paracetamol | Drug | group Paracetamol |
| Tramadol/Paracetamol combination2 tablets of tramadol/paracetamol combination (32.5mg/325mg) | Drug | group Tramadol/Paracetamol combination |
| Placebo Oral Tablet2 tablets of placebo | Drug | group Placebo |
Primary outcome
use of rescue opioids
Time frame: DURING emergency department stay
decreased consumption of intravenous morphine
3 secondary outcomes
patient satisfaction
Time frame: When quitting emergency department
Length of emergency department stay
Time frame: Until emergency department discharge
Pain intensity at emergency department discharge
Time frame: At emergency department 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 30 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol and Tramadol/Paracetamol combination in people with Acute Pain, run by University of Monastir.
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 4 inclusion and 3 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 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
use of rescue opioids (time frame: DURING emergency department stay). 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 Nov 2017.