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Completed

NCT Number: NCT02477007

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.

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Key information

Conditions

Pain Long-bone Fractures Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Paediatric emergency Armand Trousseau hospital

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • suspected femur fracture
  • open fracture
  • pregnant women in the third trimester

Treatment and study plan

Paracetamol

Drug

Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g).

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Degree of pain measured by the EVENDOL score

    Time frame: after immobilisation

    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.

  2. Degree of pain measured by the EVENDOL score

    Time frame: 15 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.

  3. Degree of pain measured by the EVENDOL score

    Time frame: 60 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.

  4. Degree of pain measured by the EVENDOL score

    Time frame: 90 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.

  5. Degree of pain measured by the EVENDOL score

    Time frame: 120 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.

  6. Degree of pain measured by the Visual Analog Scale

    Time frame: after immobilisation

    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.

  7. Degree of pain measured by the Visual Analog Scale

    Time frame: 15 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.

  8. Degree of pain measured by the Visual Analog Scale

    Time frame: 60 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.

  9. Degree of pain measured by the Visual Analog Scale

    Time frame: 90 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.

  10. Degree of pain measured by the Visual Analog Scale

    Time frame: 120 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.

  11. Tolerance of ibuprofen

    Time frame: 15 minutes

    occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.

  12. Tolerance of ibuprofen

    Time frame: 30 minutes

    occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.

  13. Tolerance of ibuprofen

    Time frame: 60 minutes

    occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.

  14. Tolerance of ibuprofen

    Time frame: 90 minutes

    occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.

  15. Tolerance of ibuprofen

    Time frame: 120 minutes

    occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.

  16. Tolerance of paracetamol

    Time frame: 15 minutes

    Occurrence of rash or hives or itching or swelling

  17. Tolerance of paracetamol

    Time frame: 30 minutes

    Occurrence of rash or hives or itching or swelling

  18. Tolerance of paracetamol

    Time frame: 60 minutes

    Occurrence of rash or hives or itching or swelling

  19. Tolerance of paracetamol

    Time frame: 90 minutes

    Occurrence of rash or hives or itching or swelling

  20. Tolerance of paracetamol

    Time frame: 120 minutes

    Occurrence of rash or hives or itching or swelling

  21. Tolerance of morphine

    Time frame: 15 minutes

    heart and respiratory rates,

  22. Tolerance of morphine

    Time frame: 30 minutes

    heart and respiratory rates,

  23. Tolerance of morphine

    Time frame: 60 minutes

    heart and respiratory rates,

  24. Tolerance of morphine

    Time frame: 90 minutes

    heart and respiratory rates,

  25. Tolerance of morphine

    Time frame: 120 minutes

    heart and respiratory rates,

  26. Tolerance of morphine

    Time frame: 15 minutes

    oxygen saturation

  27. Tolerance of morphine

    Time frame: 30 minutes

    oxygen saturation

  28. Tolerance of morphine

    Time frame: 60 minutes

    oxygen saturation

  29. Tolerance of morphine

    Time frame: 90 minutes

    oxygen saturation

  30. Tolerance of morphine

    Time frame: 120 minutes

    oxygen saturation

  31. Tolerance of morphine

    Time frame: 15 minutes

    occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness

  32. Tolerance of morphine

    Time frame: 30 minutes

    occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness

  33. Tolerance of morphine

    Time frame: 60 minutes

    occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness

  34. Tolerance of morphine

    Time frame: 90 minutes

    occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness

  35. Tolerance of morphine

    Time frame: 120 minutes

    occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Phase III Clinical Trial Studying Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children

Acronym: MORPHAPAIN

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2015
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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