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Pain management after operative treatment of extremity fractures, a randomized clinical trial

Pain management after operative treatment of extremity fractures, a randomized clinical trial - Pain management after extremity fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37699
Enrollment
60
Registered
2012-05-14
Start date
2012-07-03
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

pijn broken bones Pain after fractures

Interventions

Group 1: paracetamol max 1gr per day 'on demand' for a maximum of two weeks. Group 2: tramadol max 150-300 mg per day 'on demand' for a maximum of two weeks.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All adult patients (age > 18) who will undergo surgical treatment for an extremity fracture treated in the Academic Medical Center Amsterdam.

Exclusion criteria

Exclusion criteria: Pregnant, breastfeeding or possibly pregnant patients, patients with relevant drug allergies and children will be excluded from study participation Further exclusion criteria include: 1) another fracture at any site; 2) pathological fractures; 3) inability to fill out questionnaires; 4) polytrauma patients with other significant injuries outside the skeletal system; 5) patients already receiving any form of analgesic prior to injury; 6) liver or renal dysfunction; 7) diagnosed gastric disease; 8) diagnosed constipation 9) patients receiving MAO-inhibitors.

Design outcomes

Primary

MeasureTime frame
The main study parameters are the outcomes of the pain/satisfaction Numeric Rating Scale.

Secondary

MeasureTime frame
The secondary study parameters are the outcomes of the self-efficacy scale and the disability questionnaire.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)