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:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT01549002
Eligibility Criteria:
Inclusion Criteria:
* Patient is 4 years of age up to their 18th birthday
* Patient has a cutaneous abscess for which an I\&D is to be performed
Exclusion Criteria:
* Patient's parent doesn't speak English or Spanish
* Patient has developmental delay or neurological impairment
* Patient has altered mental status
* Known hypersensitivity to study drugs (fentanyl, morphine sulfate, lidocaine, LMX4®)
* The presence of significant blood or mucous in the nares despite blowing nose or suctioning
* Severe renal or liver dysfunction, signs of respiratory distress or depression, any respiratory distress, chronic and severe asthma, upper airway obstruction, suspected gastrointestinal obstruction, suspected paralytic ileus
* Narcotic analgesia within 4 hours of ED physician evaluation
* Need for moderate sedation, deep sedation, or general anesthesia
* Need for subspecialty consultation to perform the I\&D
* Need for I\&D of more than 1 skin abscess
* Cutaneous abscesses located on the genitals, breasts, face, or neck
* Previous enrollment in the study
* Patients with chronic pain syndromes (sickle cell disease, cancer, arthritis, inflammatory bowel disease)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT01549002
Study Brief:
Protocol Section:
NCT01549002