Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
Information source: University Hospital, Toulouse
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Condition(s) targeted: Severe, Acute Pain in a Pre-hospital Setting
Intervention: morphine (Drug); morphine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Hospital, Toulouse Official(s) and/or principal investigator(s): Jean-Louis DUCASSE, Principal Investigator, Affiliation: University Hospital Toulouse, FRANCE
Summary
Efficacy and safety of morphine titration on acute pain in emergency medical mobile units
with initial bolus of 0. 1 mg/kg plus 0. 05 mg/kg versus morphine titration with initial bolus
of 0. 05 mg/kg plus 0. 025 mg/kg
Clinical Details
Official title: Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration
Secondary outcome: Time to obtain an analgesia, defined by a VRS < or = 30Patients' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak) Investigators' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak) Safety evaluation
Detailed description:
STUDY OBJECTIVE : Assess the efficacy of a morphine dose of 0. 1 mg/kg versus a morphine dose
of 0. 05 mg/kg in pre-hospital pain METHODS : Consecutive patients with severe, acute pain
defined as a verbal rating scale (VRS) of 60/100 or higher may be included. 106 patients at
all are required in the study. They will be randomised in two groups : group A will receive
an initial intravenous injection of 0. 05 mg/kg then injections of 0. 025 mg/kg every 5
minutes and group B will receive an initial intravenous injection 0. 1 mg/kg then injections
of 0. 05 mg/kg every 5 minutes. The pain scale will be checked every 5 minutes during 30
minutes. The titration will be stopped before, if the VRS is < or = 30. The patient will be
followed during the study until 60 minutes.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Severe, acute pain defined by a VRS of 60/100 or higher
- Male or female over 18 years
- Cared by a medical emergency care unit
- Written informed consent
- Affiliated to social security
Exclusion Criteria:
- A known opioid or paracetamol hypersensitivity
- Patient not agree ta participate at the study
- Pregnancy
- Uncontrolled epilepsia
- Incapacity to understand the VRS
- Renal, respiratory, or liver disease
- Patients who have received sedative drugs or alcohol (< 6h)
- Acute respiratory, haemodynamic or neurologic failure
- Patients who have already received an analgesic (< 6h)
- Drug addiction
- Patients under protection of justice
Locations and Contacts
SAMU 31 Hôpital PURPAN, Toulouse 31059, France
Additional Information
Observatoire Régional Urgences Midi-Pyrénées, Rapport annuel sur l'activité des services d'urgence 2004
Related publications: Ricard-Hibon A, Leroy N, Magne M, Leberre A, Chollet C, Marty J. [Evaluation of acute pain in prehospital medicine]. Ann Fr Anesth Reanim. 1997;16(8):945-9. French. Ricard-Hibon A, Marty J. Prise en charge de la douleur en milieu préhospitalier, In SFAR, Conférences d'actualisation 2001, Paris, Elsevier,2001;pp 709-22 SFAR. Quelles sont les modalités de réalisation d'une sédation et/ou d'une analgésie du malade en ventilation spontanée. In : SFAR eds. Modalités de la sédation et/ou de l'analgésie en situation extrahospitalière : Conférence d'experts. Paris, Elsevier;2000;pp 37-51 SFUM. Troisième conférence de consensus en médecine d'urgence de la Société francophone d'urgence médicale. Le traitement médicamenteux de la douleur de l'adulte dans un service d'accueil et d'urgence. Réan Urg 1993; 2:321-7
Starting date: September 2005
Last updated: February 25, 2010
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