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.

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. - Treatment of acute locomotoric pain in the geriatric patient

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002379-89-BE

Enrollment

200

Registered

2016-07-08

Start date

2016-09-18

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute locomotoric pain in the geriatric patient.

Interventions

Trade Name: TRADONAL Retard 50 mg, capsules met verlengde afgifte, hard Product Name: Tradonal Retard 50 mg Pharmaceutical Form: Capsule, hard INN or Proposed INN: TRAMADOL HYDROCHLORIDE Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - = 70 years - Acute locomotoric pain (inclusion within 72 hours after onset of pain), treated conservatively: o Fractures: hip, shoulder, wrist, vertebra o Exacerbation osteoarthrosis o Exacerbation degenerative low back pain - Acute severe pain: o NRS = 5 o Possibility to NRS and informed consent o Acute pain o Hospitalised 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

Exclusion criteria

Exclusion criteria: - < 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary end point(s): safety (adverse events);Timepoint(s) of evaluation of this end point: during 7 days	—

Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

Bimetra.Clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026