An open randomised trial of patient controlled analgesia (PCA) versus routine care in the Emergency Department - PAin SoluTions In the Emergency Setting (PASTIES)

Phase 1

• Conditions: Patients presenting to the Emergency Department in severe pain from either musculoskeletal injury or non-traumatic abdominal pain.

• Registration Number: EUCTR2011-000194-31-GB
• Lead Sponsor: Plymouth Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

•Adult patients aged between 18 and 75 years of age inclusive. •Traumatic injuries or non-traumatic abdominal pain. •In severe pain on arrival in the Emergency Department. •Admission to hospital is intended at the time of enrolment. •Provision of informed consent to participate.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Patients over 75 years •Patients with a reduced conscious level •Inability to operate a PCA device. •Patients who cannot understand the study information (e.g. due to pre-existing dementia, learning difficulties, or intoxication). •Patients with chronic pain. •Patients who are opioid tolerant. •Patients with active opioid addiction. •Patients with a history of renal failure. •Allergy or other contraindication to morphine. •Hypotension (systolic blood pressure <90mmHg). •Patients in police custody, or prisoners. •Inability to gain IV access. •Patients who are likely to be definitively treated in the ED and discharged. •Patients who are pregnant or breast-feeding. •Open fractures (excluded because this group of patients will undergo surgery within six hours of injury according to national standards). •Patients on other predetermined analgesia pathway (e.g. regional anaesthesia). •Previous participation in this study. •Current participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified