PainPhase 3MORPHAPAINNCT02477007
Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children
A Phase 3 study testing Paracetamol, Ibuprofen and paracetamol + ibuprofen in people with Pain and Long-bone Fractures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Pain, Long-bone Fractures
- What is being tested?
- Paracetamol, Ibuprofen and paracetamol + ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2015to 21 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 2 through 17 years (17 years included)
- suspected fracture of a long bone requiring morphine analgesia (VAS ≥ 60/100 or Evendol ≥ 7/15 at the arrival at emergency department)
- within the first 12 hours after the injury
- at least one signed parental informed consent
- affiliated to health insurance
Who cannot join
- analgesic treatment within the 6 hours before inclusion
- contraindication to one of the experimental drug: Paracetamol or Ibuprofen
- contraindication to Morphine
- cognitive impairment
- multiple injuries
- resuscitation manœuvres
Show all 9Show fewer
- suspected femur fracture
- open fracture
- pregnant women in the third trimester
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Clinical Trial Studying Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children
The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.
Read the detailed description
Long-bone fractures are a very common complain for visits in paediatric emergency departments. Since these fractures are often very painful, morphine is considered the cornerstone treatment in case of severe pain. Very few data are available concerning the assessment of analgesic treatment in this condition. In our previous study, less than 50% of patients with a limb fracture had a Visual Analog Scale (VAS) ≤ 30 mm after morphine administration. Thus, one study make the hypothesis that the use of a combination of morphine and/or paracetamol and/or NSAID could be an effective and safe option for the treatment of pain due to long bone fractures. We undertake to compare different combinations of paracetamol and ibuprofen with morphine to determine the efficacy and safety of these strategies in emergency department paediatric patients with acute traumatic limb pain.
The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.
Second objectives are
- to compare the long term analgesic efficacy of 4 analgesic regimens a)ibuprofen/morphine, b)paracetamol/morphine, c)ibuprofen/paracetamol/morphine and d)morphine for long bone fracture management in the paediatric emergency department.
- To assess the tolerance of these 4 regimens.
The study is considered as a success if children 2-6 years (6 years included) have a pain score Evendol < 5 and children 7-17 years (17 years included) have a pain score assessed by Visual Analog Scale (VAS) ≤ 30 without additional analgesic treatment 30 minutes after drug administration.
- Conditions
- Pain, Long-bone Fractures
- Being tested
- Paracetamol, Ibuprofen, paracetamol + ibuprofen, Placebo
- Keywords
- Paediatric emergency, pain, long-bones fractures, morphine, ibuprofen, paracetamol, children
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g).
IbuprofenDrug
Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg).
paracetamol + ibuprofenDrug
Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g) Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg).
PlaceboDrug
Placebo will have the closest flavour, smell and aspect to the active substances, respectively paracetamol and ibuprofen. Placebo will be prepared in bottles with a fake label of active substances for a better blinding both for the nurse and the patient. Labels will be hiding by a mask.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen+placebo of paracetamol | Experimental | Patients will receive in addition to morphine (usual care) ibuprofen and placebo of paracetamol Receives: Drug: Ibuprofen; Drug: Placebo |
| Paracetamol + placebo of ibuprofen | Experimental | Patients will receive in addition to morphine (usual care) paracetamol and placebo of ibuprofen Receives: Drug: Paracetamol; Drug: Placebo |
| Paracetamol + ibuprofen | Experimental | Patients will receive in addition to morphine (usual care) paracetamol and ibuprofen Receives: Drug: paracetamol + ibuprofen |
| Placebo of paracetamol + placebo of ibuprofen | Placebo comparator | Patients will receive morphine alone(usual care). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old. Success: children 2-6 years (6 years included) with a pain score Evendol < 5 without additional analgesic treatment at 30 minutes after drug administration (DA)
Measured: 30 minutes
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children. Success: children 7-17 years with pain score assessed by Visual Analog Scale (VAS) ≤ 30, without additional analgesic treatment at 30 minutes after drug administration (DA)
Measured: 30 minutes
Secondary outcomes (35)
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old.
Measured: after immobilisation
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old.
Measured: 15 minutes
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old.
Measured: 60 minutes
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old.
Measured: 90 minutes
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old.
Measured: 120 minutes
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children.
Measured: after immobilisation
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children.
Measured: 15 minutes
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children.
Measured: 60 minutes
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children.
Measured: 90 minutes
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children.
Measured: 120 minutes
Tolerance of ibuprofen
occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.
Measured: 15 minutes
Tolerance of ibuprofen
occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.
Measured: 30 minutes
Tolerance of ibuprofen
occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.
Measured: 60 minutes
Tolerance of ibuprofen
occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.
Measured: 90 minutes
Tolerance of ibuprofen
occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.
Measured: 120 minutes
Tolerance of paracetamol
Occurrence of rash or hives or itching or swelling
Measured: 15 minutes
Tolerance of paracetamol
Occurrence of rash or hives or itching or swelling
Measured: 30 minutes
Tolerance of paracetamol
Occurrence of rash or hives or itching or swelling
Measured: 60 minutes
Tolerance of paracetamol
Occurrence of rash or hives or itching or swelling
Measured: 90 minutes
Tolerance of paracetamol
Occurrence of rash or hives or itching or swelling
Measured: 120 minutes
Tolerance of morphine
heart and respiratory rates,
Measured: 15 minutes
Tolerance of morphine
heart and respiratory rates,
Measured: 30 minutes
Tolerance of morphine
heart and respiratory rates,
Measured: 60 minutes
Tolerance of morphine
heart and respiratory rates,
Measured: 90 minutes
Tolerance of morphine
heart and respiratory rates,
Measured: 120 minutes
Tolerance of morphine
oxygen saturation
Measured: 15 minutes
Tolerance of morphine
oxygen saturation
Measured: 30 minutes
Tolerance of morphine
oxygen saturation
Measured: 60 minutes
Tolerance of morphine
oxygen saturation
Measured: 90 minutes
Tolerance of morphine
oxygen saturation
Measured: 120 minutes
Tolerance of morphine
occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness
Measured: 15 minutes
Tolerance of morphine
occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness
Measured: 30 minutes
Tolerance of morphine
occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness
Measured: 60 minutes
Tolerance of morphine
occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness
Measured: 90 minutes
Tolerance of morphine
occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study start3 Dec 2015
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Hélène Chappuy, MD PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477007
- Sponsor's protocol ID
- P130921
- Other IDs
- 2015-001458-14, 2015
- Acronym
- MORPHAPAIN
- Status last verified
- Oct 2025
- First submitted
- 9 Apr 2015
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clark E, Plint AC, Correll R, Gaboury I, Passi B. A randomized, controlled trial of acetaminophen, ibuprofen, and codeine for acute pain relief in children with musculoskeletal trauma. Pediatrics. 2007 Mar;119(3):460-7. doi: 10.1542/peds.2006-1347.
PubMed 17332198Koller DM, Myers AB, Lorenz D, Godambe SA. Effectiveness of oxycodone, ibuprofen, or the combination in the initial management of orthopedic injury-related pain in children. Pediatr Emerg Care. 2007 Sep;23(9):627-33. doi: 10.1097/PEC.0b013e31814a6a39.
PubMed 17876251Morton NS, O'Brien K. Analgesic efficacy of paracetamol and diclofenac in children receiving PCA morphine. Br J Anaesth. 1999 May;82(5):715-7. doi: 10.1093/bja/82.5.715.
PubMed 10536549
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial Studying Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children
- ClinicalTrials.gov ID
- NCT02477007
- Acronym / sponsor ID
- MORPHAPAIN / P130921
- Conditions
- Pain, Long-bone Fractures
- Keywords
- Paediatric emergency, pain, long-bones fractures, morphine, ibuprofen, paracetamol, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 3 Dec 2015 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 22 Jun 2015 (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.
The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.
Detailed description
Long-bone fractures are a very common complain for visits in paediatric emergency departments. Since these fractures are often very painful, morphine is considered the cornerstone treatment in case of severe pain. Very few data are available concerning the assessment of analgesic treatment in this condition. In our previous study, less than 50% of patients with a limb fracture had a Visual Analog Scale (VAS) ≤ 30 mm after morphine administration. Thus, one study make the hypothesis that the use of a combination of morphine and/or paracetamol and/or NSAID could be an effective and safe option for the treatment of pain due to long bone fractures. We undertake to compare different combinations of paracetamol and ibuprofen with morphine to determine the efficacy and safety of these strategies in emergency department paediatric patients with acute traumatic limb pain.
The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.
Second objectives are
- to compare the long term analgesic efficacy of 4 analgesic regimens a)ibuprofen/morphine, b)paracetamol/morphine, c)ibuprofen/paracetamol/morphine and d)morphine for long bone fracture management in the paediatric emergency department.
- To assess the tolerance of these 4 regimens.
The study is considered as a success if children 2-6 years (6 years included) have a pain score Evendol < 5 and children 7-17 years (17 years included) have a pain score assessed by Visual Analog Scale (VAS) ≤ 30 without additional analgesic treatment 30 minutes after drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen+placebo of paracetamol | Experimental | Drug: Ibuprofen, Drug: PlaceboPatients will receive in addition to morphine (usual care) ibuprofen and placebo of paracetamol |
| Paracetamol + placebo of ibuprofen | Experimental | Drug: Paracetamol, Drug: PlaceboPatients will receive in addition to morphine (usual care) paracetamol and placebo of ibuprofen |
| Paracetamol + ibuprofen | Experimental | Drug: paracetamol + ibuprofenPatients will receive in addition to morphine (usual care) paracetamol and ibuprofen |
| Placebo of paracetamol + placebo of ibuprofen | Placebo comparator | Drug: PlaceboPatients will receive morphine alone(usual care). |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children aged 2 through 17 years (17 years included)
- suspected fracture of a long bone requiring morphine analgesia (VAS ≥ 60/100 or Evendol ≥ 7/15 at the arrival at emergency department)
- within the first 12 hours after the injury
- at least one signed parental informed consent
- affiliated to health insurance
Key exclusion criteria (9 listed)
- analgesic treatment within the 6 hours before inclusion
- contraindication to one of the experimental drug: Paracetamol or Ibuprofen
- contraindication to Morphine
- cognitive impairment
- multiple injuries
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 |
|---|---|---|
| ParacetamolParacetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g). | Drug | Paracetamol + placebo of ibuprofen |
| IbuprofenIbuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg). | Drug | Ibuprofen+placebo of paracetamol |
| paracetamol + ibuprofenParacetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g) Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg). | Drug | Paracetamol + ibuprofen |
| PlaceboPlacebo will have the closest flavour, smell and aspect to the active substances, respectively paracetamol and ibuprofen. Placebo will be prepared in bottles with a fake label of active substances for a better blinding both for the nurse and the patient. Labels will be hiding by a mask. | Drug | Ibuprofen+placebo of paracetamol, Paracetamol + placebo of ibuprofen, Placebo of paracetamol + placebo of ibuprofen |
Primary outcome
Degree of pain measured by the EVENDOL score
Time frame: 30 minutes
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old. Success: children 2-6 years (6 years included) with a pain score Evendol < 5 without additional analgesic treatment at 30 minutes after drug administration (DA)
Degree of pain measured by the Visual Analog Scale
Time frame: 30 minutes
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children. Success: children 7-17 years with pain score assessed by Visual Analog Scale (VAS) ≤ 30, without additional analgesic treatment at 30 minutes after drug administration (DA)
35 secondary outcomes
Degree of pain measured by the EVENDOL score
Time frame: after immobilisation
Degree of pain measured by the EVENDOL score
Time frame: 15 minutes
Degree of pain measured by the EVENDOL score
Time frame: 60 minutes
Degree of pain measured by the EVENDOL score
Time frame: 90 minutes
Degree of pain measured by the EVENDOL score
Time frame: 120 minutes
Degree of pain measured by the Visual Analog Scale
Time frame: after immobilisation
Degree of pain measured by the Visual Analog Scale
Time frame: 15 minutes
Degree of pain measured by the Visual Analog Scale
Time frame: 60 minutes
Degree of pain measured by the Visual Analog Scale
Time frame: 90 minutes
Degree of pain measured by the Visual Analog Scale
Time frame: 120 minutes
Tolerance of ibuprofen
Time frame: 15 minutes
Tolerance of ibuprofen
Time frame: 30 minutes
Tolerance of ibuprofen
Time frame: 60 minutes
Tolerance of ibuprofen
Time frame: 90 minutes
Tolerance of ibuprofen
Time frame: 120 minutes
Tolerance of paracetamol
Time frame: 15 minutes
Tolerance of paracetamol
Time frame: 30 minutes
Tolerance of paracetamol
Time frame: 60 minutes
Tolerance of paracetamol
Time frame: 90 minutes
Tolerance of paracetamol
Time frame: 120 minutes
Tolerance of morphine
Time frame: 15 minutes
Tolerance of morphine
Time frame: 30 minutes
Tolerance of morphine
Time frame: 60 minutes
Tolerance of morphine
Time frame: 90 minutes
Tolerance of morphine
Time frame: 120 minutes
Tolerance of morphine
Time frame: 15 minutes
Tolerance of morphine
Time frame: 30 minutes
Tolerance of morphine
Time frame: 60 minutes
Tolerance of morphine
Time frame: 90 minutes
Tolerance of morphine
Time frame: 120 minutes
Tolerance of morphine
Time frame: 15 minutes
Tolerance of morphine
Time frame: 30 minutes
Tolerance of morphine
Time frame: 60 minutes
Tolerance of morphine
Time frame: 90 minutes
Tolerance of morphine
Time frame: 120 minutes
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 20 Nov 2025.
- Background: PubMed 17332198Clark E, Plint AC, Correll R, Gaboury I, Passi B. A randomized, controlled trial of acetaminophen, ibuprofen, and codeine for acute pain relief in children with musculoskeletal trauma. Pediatrics. 2007 Mar;119(3):460-7. doi: 10.1542/peds.2006-1347.
- Background: PubMed 17876251Koller DM, Myers AB, Lorenz D, Godambe SA. Effectiveness of oxycodone, ibuprofen, or the combination in the initial management of orthopedic injury-related pain in children. Pediatr Emerg Care. 2007 Sep;23(9):627-33. doi: 10.1097/PEC.0b013e31814a6a39.
- Background: PubMed 10536549Morton NS, O'Brien K. Analgesic efficacy of paracetamol and diclofenac in children receiving PCA morphine. Br J Anaesth. 1999 May;82(5):715-7. doi: 10.1093/bja/82.5.715.
- Individual participant dataSharing planned: No
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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.
Hélène Chappuy, MD PhD principal investigator
Study Principal Investigator
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, Ibuprofen and paracetamol + ibuprofen in people with Pain and Long-bone Fractures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 9 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 20 Nov 2025. 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 France. 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. 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.
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?
Degree of pain measured by the EVENDOL score (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 NCT02477007, which also lists 3 linked publications.
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 20 Nov 2025.