Severe, Acute Pain in a Pre-hospital Setting Clinical Trial
Official title:
Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
Verified date | May 2017 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 106 |
Est. completion date | March 2006 |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | SAMU 31 Hôpital PURPAN | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Bounes V, Charpentier S, Houze-Cerfon CH, Bellard C, Ducassé 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.2 — View 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. French. — View 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
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration | |||
Secondary | Time to obtain an analgesia, defined by a VRS < or = 30 | |||
Secondary | Patients' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak) | |||
Secondary | Investigators' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak) | |||
Secondary | Safety evaluation |