EUCTR2012-000680-24-NL
Active, not recruiting
Phase 1
Pain management after operative treatment of extremity fractures, a randomized clinical trial - Pain management after extremity fractures
ConditionsPatient satisfaction with pain relief and pain intensity (Numeric Rating Scale) will be investigated.Also to find predictors we will investigate: age, sex, trauma-site, fracture type, AIS score, multi-trauma, mechanism of injury,MedDRA version: 17.1Level: HLTClassification code 10024956Term: Lower limb fracturesSystem Organ Class: 100000004859MedDRA version: 19.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865MedDRA version: 19.1Level: LLTClassification code 10033762Term: ParacetamolSystem Organ Class: 100000004848MedDRA version: 17.1Level: HLTClassification code 10046292Term: Upper limb fracturesSystem Organ Class: 100000004859Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patient satisfaction with pain relief and pain intensity (Numeric Rating Scale) will be investigated.Also to find predictors we will investigate: age, sex, trauma-site, fracture type, AIS score, multi-trauma, mechanism of injury,
- Sponsor
- Academisch Medisch Centrum
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All adult patients (age \> 18\) who will undergo surgical treatment for an extremity fracture treated in the Academic Medical Center Amsterdam.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 60
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
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.
Outcomes
Primary Outcomes
Not specified
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