Post Traumatic PainPhase 3NCT01123551
Efficacy Study of Nebulized Morphine and Intravenous Morphine in Post Traumatic Pain
A Phase 3 study testing nebulized morphine and Intravenous morphine in people with Post Traumatic Pain, run by University of Monastir at 1 site in Tunisia.
Trial summary
In the emergency department, 60% of patients have an acute pain. Appropriate management of acute pain is a public health priority according to who recommendations. Nebulized morphine has been extensively studied in children but less well in adults. Read more about this study
- Who is it for?
- Ages 8 to 50 years
- Conditions the study is for
- Post Traumatic Pain
- What is being tested?
- nebulized morphine and Intravenous morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTunisia
- Study dates
- Jun 2010to Jul 2014
- 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 8 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Post-traumatic pain with visual analog pain scale( VAPS) ≥ 50%
- Age between 8 and 50 years.
Who cannot join
- Glasgow coma scale (GCS)< 14,
- Severe injury ,
- Hypotension : blood systolic pressure < 90 mmhg,
- Bradypnea < 12 cpm or SaO2< 90%,
- Chronic pain treatment,
- Aspirin or paracetamol treatment within 6 hours of emergency presentation,
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- Nasal trauma, rhinitis, nasal obstruction,
- Incapacity to cooperate,
- Opiate allergy,
- Drug addiction,
- Pregnancy, breast feeding,
- Severe renal and liver failure and chronic obstructive pulmonary disease(COPD)
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Fattouma Bourguiba University Hospital
Monastir, Monastir Governorate, 5000
About this study
Official title: Nebulized Morphine Versus Intravenous Morphine in the Management of Post Traumatic Pain in Emergency Department (ED)
In the emergency department, 60% of patients have an acute pain. Appropriate management of acute pain is a public health priority according to who recommendations. Nebulized morphine has been extensively studied in children but less well in adults.
It offers a non-invasive route for systemic drug delivery, more rapid and less invasive than intravenous (IV) method.
- Conditions
- Post Traumatic Pain
- Being tested
- nebulized morphine, Intravenous morphine
- Keywords
- Nebulized morphine, Intravenous morphine, Post traumatic, Pain, Emergency department
- Medical subject headings
- Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulized morphineDrug
After randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached .
Intravenous morphineDrug
After randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS >30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS >30%).
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Morphine | Experimental | After randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached . Receives: Drug: nebulized morphine; Drug: Intravenous morphine |
| Intravenous morphine | Active comparator | After randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS >30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS >30%). Receives: Drug: Intravenous morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Resolution rate
resolution is defined as VAPS <30%.
Measured: one hour
Secondary outcomes (2)
rate of side effects
Dyspnea, cutaneous rush, vomiting, nausea, pruritus and dizziness.
Measured: one hour
Resolution time
Resolution time is defined as the time between the starting of the protocol and pain decrease to a Visual Analog Scale less than 30%
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123551
- Sponsor's protocol ID
- Morphine
- Status last verified
- Jul 2014
- First submitted
- 11 May 2010
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Morphine Versus Intravenous Morphine in the Management of Post Traumatic Pain in Emergency Department (ED)
- ClinicalTrials.gov ID
- NCT01123551
- Acronym / sponsor ID
- Morphine
- Conditions
- Post Traumatic Pain
- Keywords
- Nebulized morphine, Intravenous morphine, Post traumatic, Pain, Emergency department
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 May 2010 (estimated)
- 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.
In the emergency department, 60% of patients have an acute pain. Appropriate management of acute pain is a public health priority according to who recommendations. Nebulized morphine has been extensively studied in children but less well in adults.
It offers a non-invasive route for systemic drug delivery, more rapid and less invasive than intravenous (IV) method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized Morphine | Experimental | Drug: nebulized morphine, Drug: Intravenous morphineAfter randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached . |
| Intravenous morphine | Active comparator | Drug: Intravenous morphineAfter randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS >30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS >30%). |
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Post-traumatic pain with visual analog pain scale( VAPS) ≥ 50%
- Age between 8 and 50 years.
Key exclusion criteria (12 listed)
- Glasgow coma scale (GCS)< 14,
- Severe injury ,
- Hypotension : blood systolic pressure < 90 mmhg,
- Bradypnea < 12 cpm or SaO2< 90%,
- Chronic pain treatment,
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 |
|---|---|---|
| nebulized morphineAfter randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached . | Drug | Nebulized Morphine |
| Intravenous morphineAfter randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS >30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS >30%). | Drug | Intravenous morphine, Nebulized Morphine |
Primary outcome
1. Resolution rate
Time frame: one hour
resolution is defined as VAPS <30%.
2 secondary outcomes
rate of side effects
Time frame: one hour
Resolution time
Time frame: one hour
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 23 Jul 2014.
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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.
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 nebulized morphine and Intravenous morphine in people with Post Traumatic Pain, 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 12 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 23 Jul 2014. 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?
1. Resolution rate (time frame: one hour). 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 23 Jul 2014.