Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT01887951
Eligibility Criteria:
Inclusion Criteria:
* Patients with acute pain, with pain score greater than 3, presenting with musculo-skeletal trauma (limbs or back) pain are eligible
* Conscious, haemodynamically stable condition (BP greater than 90/60)
* Age more than 16 years old
Exclusion Criteria:
General
* Females who are nursing or with a positive pregnancy test (pregnant)
* Patients with major head injury or impaired consciousness
* Acute intoxication with drugs or alcohol, or other conditions that might impair ability to score pain
* Chronic pain requiring ongoing use of analgesics
* Abdominal or chest pain (for the purpose of this initial implementation study)
Penthrox only
* Known pre-existing renal or hepatic impairment
* Hypersensitivity to fluorinated anaesthetics or a history of possible adverse reactions in either the patients or relatives (malignant hyperthermia)
* Concomitant use of nephrotoxic medications such as gentamicin or tetracycline
Tramadol only
* Any allergies to tramadol or codeine
* Any history of seizures, epilepsy
* Patients who are taking anti-depressants
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01887951
Study Brief:
Protocol Section:
NCT01887951