Multiple TraumaPhase 3NCT05630222
Evaluation of Effect of Intravenous Morphine vs Intravenous Ibuprofen and Acetaminophen vs Intravenous Ibuprofen
A Phase 3 study testing Ibuprofen 800 mg, Morphine Sulfate and Ibuprofen 400 mg plus Acetaminophen 1000 mg in people with Multiple Trauma and Acute Pain Due to Trauma, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Pain is an inseparable symptom of fractures and is the most important and common symptom that brings patients to medical centers; Therefore, paying attention to pain and its control is very important in the examination and treatment of fractures, and painkillers are usually needed for effective pain control. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Trauma, Acute Pain Due to Trauma
- What is being tested?
- Ibuprofen 800 mg, Morphine Sulfate and Ibuprofen 400 mg plus Acetaminophen 1000 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIran
- Study dates
- 15 Mar 2022to 15 Mar 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosing a closed fracture of any of the bones of the body by an emergency medicine specialist
- Informed consent of the patient or his family to participate in the study
- Age 18 to 55 years
- Pain score of higher than or equal to 6 on the VAS scale
- Informed consent of the patient or family during the study
- No history of liver or kidney failure
Show all 17Show fewer
- No history of gastrointestinal bleeding
- No history of heart failure
- No history of allergy to study drugs
- Absence of addiction (the patient is asked)
- Not decreased level of consciousness
- Lack of evidence of increased intra-cerebral pressure
- Not having an open fracture
- Absence of breathing disorders and respiratory problems
- No history of asthma
- Lack of history of frequent use of painkillers
- Not receiving any form of pain killer in the last few hours
Who cannot join
- Occurrence of any type of drug reaction or unusual complication during the study period
- Simultaneous Head trauma
- Simultaneous damage of nerves and blood vessels
- Multiple fractures
- Fracture other than limb
- Evidence of increased intra-cerebral pressure
- Decreased level of consciousness
- Breathing disorders and respiratory problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effect of Intravenous Morphine vs Intravenous Ibuprofen and Acetaminophen vs Intravenous Ibuprofen on Pain Relief in Patients With Closed Extremity Fracture Admitted in Alzahra and Ayatollah Kashani Hospitals in 2022
Pain is an inseparable symptom of fractures and is the most important and common symptom that brings patients to medical centers; Therefore, paying attention to pain and its control is very important in the examination and treatment of fractures, and painkillers are usually needed for effective pain control. About 70-90% of the patients who go to the emergency room due to injuries have organ injuries. Among these patients, those who suffer from fractures endure severe pain, and since only 10% of patients have open fractures, the pain management of patients with closed fractures is particularly important. Various medicinal compounds have been used so far to control the pain of fractured patients, including opioid compounds such as morphine, non-steroidal anti-inflammatory drugs such as ibuprofen and acetaminophen. Opioids are the main drug class for pain control in fractures, but since they have significant side effects, various studies have been conducted in the field of comparing the anti-inflammatory effect of different drugs in fractures, and the effect of various combinations compared to opioids has been investigated. Non-steroidal anti-inflammatories are always considered as an alternative to opioids and acetaminophen has also been considered to reduce the dosage of opioids, so in this study the effect of three combinations of intravenous morphine and ibuprofen plus intravenous acetaminophen and intravenous ibuprofen on pain levels in patients with a closed limb fracture will be investigated.
This study is a blind randomized clinical trial, which investigates and compares the effect of intravenous morphine (Daropakhsh Company) with intravenous ibuprofen (Caspian Taamin Company) and intravenous acetaminophen (Caspian Taamin Company) with intravenous ibuprofen (Caspian Taamin Company) in reducing the pain of patients with closed limb fractures. The population investigated in this study will include all patients referred to the emergency room of Al-Zahra and Ayatollah Kashani educational centers in Isfahan city in 2022-2023.
Read the detailed description
The study subjects are classified into 3 groups by computerized random allocation method, the first group will receive 0.1 mg/kg of intravenous morphine (Daropakhsh company) and the second group will take 400 mg of intravenous ibuprofen (Caspian Taamin company) plus 1 gram of intravenous acetaminophen (Caspian company). Tamin) and the third group receives 800 mg of intravenous ibuprofen (Caspian Taamin Company).This study is a blind randomized clinical trial, which investigates and compares the effect of intravenous morphine with intravenous ibuprofen and intravenous acetaminophen with intravenous ibuprofen.
- Conditions
- Multiple Trauma, Acute Pain Due to Trauma
- Being tested
- Ibuprofen 800 mg, Morphine Sulfate, Ibuprofen 400 mg plus Acetaminophen 1000 mg
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 800 mgDrug
Ibuprofen from Caspian Taamin Company
Morphine SulfateDrug
Morphine Sulfate from Darupakhsh Company
Ibuprofen 400 mg plus Acetaminophen 1000 mgDrug
Both from Caspian Taamin Company
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Active comparator | Ibuprofen 800 mg IV infusion over 20 min. Receives: Drug: Ibuprofen 800 mg |
| Morphine | Active comparator | Morphine Sulfate 0.1 mg/kg IV Receives: Drug: Morphine Sulfate |
| Ibuprofen plus Acetaminophen | Active comparator | Ibuprofen 400 mg plus Acetaminophen 1000 mg IV infusion over 20 min. Receives: Drug: Ibuprofen 400 mg plus Acetaminophen 1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score (VAS)
a scale for measuring the extent of pain relief
Measured: Change from baseline at 60 minutes
Secondary outcomes (4)
HR
Heart rate
Measured: Change from baseline at 60 minutes
RR
Respiratory rate
Measured: Change from baseline at 60 minutes
SpO2
Blood oxygen saturation
Measured: Change from baseline at 60 minut
BP
Blood Pressure
Measured: Change from baseline at 60 minut
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start15 Mar 2022
- Primary completion15 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Nasr Isfahani, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630222
- Sponsor's protocol ID
- 3401308
- Status last verified
- Sep 2023
- First submitted
- 18 Nov 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be possible to share data if requeste
Publications
Nasr Isfahani M, Etesami H, Ahmadi O, Masoumi B. Comparing the efficacy of intravenous morphine versus ibuprofen or the combination of ibuprofen and acetaminophen in patients with closed limb fractures: a randomized clinical trial. BMC Emerg Med. 2024 Jan 25;24(1):15. doi: 10.1186/s12873-024-00933-y.
PubMed 38273252
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effect of Intravenous Morphine vs Intravenous Ibuprofen and Acetaminophen vs Intravenous Ibuprofen on Pain Relief in Patients With Closed Extremity Fracture Admitted in Alzahra and Ayatollah Kashani Hospitals in 2022
- ClinicalTrials.gov ID
- NCT05630222
- Acronym / sponsor ID
- 3401308
- Conditions
- Multiple Trauma, Acute Pain Due to Trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 29 Nov 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.
Pain is an inseparable symptom of fractures and is the most important and common symptom that brings patients to medical centers; Therefore, paying attention to pain and its control is very important in the examination and treatment of fractures, and painkillers are usually needed for effective pain control. About 70-90% of the patients who go to the emergency room due to injuries have organ injuries. Among these patients, those who suffer from fractures endure severe pain, and since only 10% of patients have open fractures, the pain management of patients with closed fractures is particularly important. Various medicinal compounds have been used so far to control the pain of fractured patients, including opioid compounds such as morphine, non-steroidal anti-inflammatory drugs such as ibuprofen and acetaminophen. Opioids are the main drug class for pain control in fractures, but since they have significant side effects, various studies have been conducted in the field of comparing the anti-inflammatory effect of different drugs in fractures, and the effect of various combinations compared to opioids has been investigated. Non-steroidal anti-inflammatories are always considered as an alternative to opioids and acetaminophen has also been considered to reduce the dosage of opioids, so in this study the effect of three combinations of intravenous morphine and ibuprofen plus intravenous acetaminophen and intravenous ibuprofen on pain levels in patients with a closed limb fracture will be investigated.
This study is a blind randomized clinical trial, which investigates and compares the effect of intravenous morphine (Daropakhsh Company) with intravenous ibuprofen (Caspian Taamin Company) and intravenous acetaminophen (Caspian Taamin Company) with intravenous ibuprofen (Caspian Taamin Company) in reducing the pain of patients with closed limb fractures. The population investigated in this study will include all patients referred to the emergency room of Al-Zahra and Ayatollah Kashani educational centers in Isfahan city in 2022-2023.
Detailed description
The study subjects are classified into 3 groups by computerized random allocation method, the first group will receive 0.1 mg/kg of intravenous morphine (Daropakhsh company) and the second group will take 400 mg of intravenous ibuprofen (Caspian Taamin company) plus 1 gram of intravenous acetaminophen (Caspian company). Tamin) and the third group receives 800 mg of intravenous ibuprofen (Caspian Taamin Company).This study is a blind randomized clinical trial, which investigates and compares the effect of intravenous morphine with intravenous ibuprofen and intravenous acetaminophen with intravenous ibuprofen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Active comparator | Drug: Ibuprofen 800 mgIbuprofen 800 mg IV infusion over 20 min. |
| Morphine | Active comparator | Drug: Morphine SulfateMorphine Sulfate 0.1 mg/kg IV |
| Ibuprofen plus Acetaminophen | Active comparator | Drug: Ibuprofen 400 mg plus Acetaminophen 1000 mgIbuprofen 400 mg plus Acetaminophen 1000 mg IV infusion over 20 min. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Diagnosing a closed fracture of any of the bones of the body by an emergency medicine specialist
- Informed consent of the patient or his family to participate in the study
- Age 18 to 55 years
- Pain score of higher than or equal to 6 on the VAS scale
- Informed consent of the patient or family during the study
Key exclusion criteria (8 listed)
- Occurrence of any type of drug reaction or unusual complication during the study period
- Simultaneous Head trauma
- Simultaneous damage of nerves and blood vessels
- Multiple fractures
- Fracture other than limb
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 |
|---|---|---|
| Ibuprofen 800 mgIbuprofen from Caspian Taamin Company | Drug | Ibuprofen |
| Morphine SulfateMorphine Sulfate from Darupakhsh Company | Drug | Morphine |
| Ibuprofen 400 mg plus Acetaminophen 1000 mgBoth from Caspian Taamin Company | Drug | Ibuprofen plus Acetaminophen |
Primary outcome
Visual analogue score (VAS)
Time frame: Change from baseline at 60 minutes
a scale for measuring the extent of pain relief
4 secondary outcomes
HR
Time frame: Change from baseline at 60 minutes
RR
Time frame: Change from baseline at 60 minutes
SpO2
Time frame: Change from baseline at 60 minut
BP
Time frame: Change from baseline at 60 minut
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 7 Sep 2023.
- Derived from this study: PubMed 38273252Nasr Isfahani M, Etesami H, Ahmadi O, Masoumi B. Comparing the efficacy of intravenous morphine versus ibuprofen or the combination of ibuprofen and acetaminophen in patients with closed limb fractures: a randomized clinical trial. BMC Emerg Med. 2024 Jan 25;24(1):15. doi: 10.1186/s12873-024-00933-y.
- Individual participant dataSharing planned: Yes. It will be possible to share data if requeste
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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 Ibuprofen 800 mg, Morphine Sulfate and Ibuprofen 400 mg plus Acetaminophen 1000 mg in people with Multiple Trauma and Acute Pain Due to Trauma, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 17 inclusion and 8 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 7 Sep 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 Iran. 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?
Visual analogue score (VAS) (time frame: Change from baseline at 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05630222, which also lists 1 linked publication.
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 7 Sep 2023.