Treatment of acute locomotoric pain in the geriatric patient: comparison of effectiveness and safety between step 2 (weak opioids) and step 3 (strong opioids) pain relief of the WHO-ladder.
- Conditions
- Acute locomotoric pain in the geriatric patient.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2016-002379-89-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
-= 70 years
-Acute locomotoric pain (inclusion within 72 hours after onset of pain), treated conservatively:
oFractures: hip, shoulder, wrist, vertebra
oExacerbation osteoarthrosis
oExacerbation degenerative low back pain
-Acute severe pain:
oNRS = 5
oPossibility to NRS and informed consent
oAcute pain
oHospitalised on geriatric ward
-Chronic pain treatment in advance: maximum step 1 (paracetamol/NSAIDs)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
-< 70 years
-Surgical treatment for musculoskeletal pain
-Inflammatory pain(gout, chondrocalcinosis), tumoral pain, organ pain, pain caused by ischemia
-Chronic pain (without exacerbation), terminal situation
-Impossibility to oral intake of medication
-Severe liver insufficiency (TA 2X normal values) or severe renal insufficiency (clearance < 30ml/min)
-Longterm opioid-use = longer than 2 weeks step 2 or 3 in the last 6 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether there is a difference in effectiveness and safety between two commonly used therapeutic strategies: step 2 versus step 3 of the WHO pain ladder.;Secondary Objective: Not applicable;Primary end point(s): pain-relief due to medication efficacy;Timepoint(s) of evaluation of this end point: 3 times a day during 7 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): safety (adverse events);Timepoint(s) of evaluation of this end point: during 7 days