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NCT02498483 · ClinicalTrials.gov registry record · Phase 4
Acetaminophen and Post Circumcision Pain Control
A Phase 4 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT02498483 is a Phase 4 study that was terminated before completion, run by Columbia University. The registered enrollment target is 11 participants.
The verdict
NCT02498483, a Phase 4 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
Infants do not routinely receive acetaminophen for pain control after circumcision. This study will determine if acetaminophen is effective at controlling infant pain after circumcision using nerve block and oral dextrose. Infants will undergo the routine circumcision procedure, and half will be randomly selected to receive half acetaminophen immediately at the end of the procedure. Afterwards, infant's vitals signs (heart rate, respiratory rate, oxygen saturation), the neonatal infant pain scale (NIPS), and salivary cortisol levels will be checked in regular intervals up to 4 hours. The NIPS is a validated pain scoring system based on the appearance of the infant. A reduction in NIPS for those infants who receive acetaminophen versus nothing will be the primary outcome to determine if the study is significant.
Interventions
- DRUG Acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-09 |
| Est. Completion | 2018-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02498483
The ClinicalTrials.gov registry entry for NCT02498483 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Acetaminophen is the first listed.
NCT02498483 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02498483 about?
NCT02498483 is a clinical study titled "Acetaminophen and Post Circumcision Pain Control". Infants do not routinely receive acetaminophen for pain control after circumcision. This study will determine if acetaminophen is effective at controlling infant pain after circumcision using nerve block and oral dextrose. Infants will undergo the routine circumcision procedure, and half will be ran...
What is the current status of trial NCT02498483?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2015-09. Estimated completion is 2018-06.
What interventions are being tested in trial NCT02498483?
The interventions under investigation include: Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT02498483?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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