Pediatric Postoperative Analgesia Herniorrhaphy Study (NCT03922048) | Clinical Trial Compass
WithdrawnPhase 2
Pediatric Postoperative Analgesia Herniorrhaphy Study
Stopped: Withdrawn due to lack of enrollment.
0Started 2023-07
Plain-language summary
This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.
Who can participate
Age range3 Years – 16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Is scheduled to undergo a unilateral open inguinal herniorrhaphy with or without mesh under general anesthesia.
* Has an American Society of Anesthesiologists Physical Status of I, II, or III.
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.
Exclusion Criteria:
* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
* Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy).
* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
* Has taken meloxicam within least 10 days prior to the scheduled surgery.
* Has been administered bupivacaine within 5 days prior to the scheduled surgery.
* Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in…
What they're measuring
1
Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf)
Timeframe: 72 hours
2
Maximum concentration (Cmax)
Timeframe: 72 hours
3
Time of occurrence of maximum concentration (Tmax)