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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT02804633
Eligibility Criteria:
Inclusion Criteria:
* Patient undergoing colorectal operation (Hartmann's procedure, sigmoidectomy, left hemicolectomy, right hemicolectomy, transverse colectomy, ileocecectomy, colo-colonic anastomosis, colorectal anastomosis, ileo-colonic anastomosis, low anterior resection, or abdominoperineal resection)
* Age range from 18 to 90 years old
* Patient providing signed, written informed consent before participation in the study
Exclusion Criteria:
* Patient younger than 18 years old or older than 90 years old
* Patient or family is unable to give consent
* Patient who use opioids or tramadol daily for \>7 days before study medication administration(patient who, in the investigator's opinion, had or was developing opioid tolerance)
* Patient who had a chronic pain condition or any significant medical disease, laboratory abnormality, or condition that, in the investigator's judgment, could have compromised the subject's welfare, ability to communicate with the study staff, complete study activities, or otherwise restricted study participation
* Patient who had hypersensitivity to opioids, acetaminophen, or the inactive ingredients of the study medication
* Patient who had known or suspected history of alcohol or drug abuse or dependence within the previous 1 year
* Patient who had impaired liver function
* Patient who had fever within first 48 hours post-operatively and required acetaminophen for fever reduction
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02804633
Study Brief:
Protocol Section:
NCT02804633