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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT01626235
Eligibility Criteria:
Inclusion Criteria:
* Eligible subjects will meet the following criteria:
1. Eligible diagnoses:
musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea
2. Age GTE 18 years;
3. Decision to discharge from ED to community already made;
4. Decision to give SPRIX, opioid, OR SPRIX + opioid rescue already made;
5. Treating clinician deems patient appropriate for continued analgesic management as an outpatient for the next 3-5 days;
6. Patient has ready touch-tone (mobile or land line) telephone access, provides number (and back-up number, if possible) and agrees (verbal or written consent as mandated by site) to answer and comply with brief IVR questionnaires daily for next 4 days.
Exclusion Criteria:
* Eligible subjects will meet none of the following criteria:
1. Patient admitted or placed on observation status from ED;
2. Patient unwilling or unable to comply with telephonic follow-up;
3. Fracture that requires surgical repair (even if at a later date);
4. Patient has diagnosis of any chronic pain syndrome;
5. Patient already routinely takes NSAID or opioid agent;
6. Treating clinician has reasonable suspicion of drug-seeking behavior or noncompliance;
7. Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01626235
Study Brief:
Protocol Section:
NCT01626235