NCT00237731

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

October 7, 2005

Last Update Submit

May 10, 2017

Conditions

Severe, Acute Pain in a Pre-hospital Setting

Keywords

Acute painMorphine titrationAnalgesiaPre-hospital care

Outcome Measures

Primary Outcomes (1)

  • A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration

Secondary Outcomes (4)

  • Time to obtain an analgesia, defined by a VRS < or = 30

  • Patients' 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

Study Arms (2)

1

EXPERIMENTAL

morphine 0.05

Drug: morphine

2

ACTIVE COMPARATOR

morphine 0.10

Drug: morphine

Interventions

morphineDRUG

morphine 0.05

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAMU 31 Hôpital PURPAN

Toulouse, 31059, France

Location

Related Publications (5)

  • 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.

    PMID: 9750642BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 18272093RESULT

Related Links

MeSH Terms

Conditions

Acute PainAgnosia

Interventions

Morphine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Jean-Louis DUCASSE

    University Hospital, Toulouse, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

September 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations

FR(1)