Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001458-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen+placebo of paracetamol | Experimental | Patients will receive in addition to morphine (usual care) ibuprofen and placebo of paracetamol |
|
| Paracetamol + placebo of ibuprofen | Experimental | Patients will receive in addition to morphine (usual care) paracetamol and placebo of ibuprofen |
|
| Paracetamol + ibuprofen | Experimental | Patients will receive in addition to morphine (usual care) paracetamol and ibuprofen |
|
| Placebo of paracetamol + placebo of ibuprofen | Placebo Comparator | Patients will receive morphine alone(usual care). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after immobilisation |
| Degree of pain measured by the EVENDOL score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hélène Chappuy, MD PhD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paediatric emergency Armand Trousseau hospital | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17332198 | Background | 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. | |
| 17876251 | Background | Koller 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ibuprofen | Drug | Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg). |
|
| paracetamol + ibuprofen | Drug | 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). |
|
| Placebo | Drug | 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. |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 120 minutes |
| Tolerance of ibuprofen | occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash. | 15 minutes |
| Tolerance of ibuprofen | occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash. | 30 minutes |
| Tolerance of ibuprofen | occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash. | 60 minutes |
| Tolerance of ibuprofen | occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash. | 90 minutes |
| Tolerance of ibuprofen | occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash. | 120 minutes |
| Tolerance of paracetamol | Occurrence of rash or hives or itching or swelling | 15 minutes |
| Tolerance of paracetamol | Occurrence of rash or hives or itching or swelling | 30 minutes |
| Tolerance of paracetamol | Occurrence of rash or hives or itching or swelling | 60 minutes |
| Tolerance of paracetamol | Occurrence of rash or hives or itching or swelling | 90 minutes |
| Tolerance of paracetamol | Occurrence of rash or hives or itching or swelling | 120 minutes |
| Tolerance of morphine | heart and respiratory rates, | 15 minutes |
| Tolerance of morphine | heart and respiratory rates, | 30 minutes |
| Tolerance of morphine | heart and respiratory rates, | 60 minutes |
| Tolerance of morphine | heart and respiratory rates, | 90 minutes |
| Tolerance of morphine | heart and respiratory rates, | 120 minutes |
| Tolerance of morphine | oxygen saturation | 15 minutes |
| Tolerance of morphine | oxygen saturation | 30 minutes |
| Tolerance of morphine | oxygen saturation | 60 minutes |
| Tolerance of morphine | oxygen saturation | 90 minutes |
| Tolerance of morphine | oxygen saturation | 120 minutes |
| Tolerance of morphine | occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness | 15 minutes |
| Tolerance of morphine | occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness | 30 minutes |
| Tolerance of morphine | occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness | 60 minutes |
| Tolerance of morphine | occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness | 90 minutes |
| Tolerance of morphine | occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness | 120 minutes |
| 10536549 | Background | Morton 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. |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided