Clinical trial NCT00237731: Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
Official title: Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Severe, Acute Pain in a Pre-hospital Setting
Keywords: Acute pain
Morphine titration
Analgesia
Pre-hospital care
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2005-10-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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

Primary outcomes:
measure: A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration
Secondary outcomes:
measure: Time to obtain an analgesia, defined by a VRS < or = 30
measure: Patients' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
measure: Investigators' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
measure: Safety evaluation
Other outcomes:
Locations:
city: Toulouse
country: France
facility: SAMU 31 Hôpital PURPAN
Study officials:
affiliation: University Hospital, Toulouse, France
name: Jean-Louis DUCASSE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0750-7658(97)82142-9. French.
citation: 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
citation: 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
citation: 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
citation: Bounes V, Charpentier S, Houze-Cerfon CH, Bellard C, Ducasse JL. Is there an ideal morphine dose for prehospital treatment of severe acute pain? A randomized, double-blind comparison of 2 doses. Am J Emerg Med. 2008 Feb;26(2):148-54. doi: 10.1016/j.ajem.2007.04.020.