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NCT01394718 · ClinicalTrials.gov registry record · Phase 3
Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients
A Phase 3 study of Pain, Postoperative, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 3
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT01394718 is a Phase 3 study of Pain, Postoperative that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 67 participants, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01394718, a Phase 3 study of Pain, Postoperative, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, randomized, double-blinded, placebo controlled trial Potential subjects will be identified from the Pre-Surgical Anesthesia Clinic visit. Parents/legal guardians will be approached about study participation at the Anesthesia outpatient pre-visit. Attending Anesthesiologist will receive e-mail notification about potential subject participation the day before the scheduled surgery. Study lab (hepatic function panel) will be collected as soon as possible after anesthesia induction by anesthesia. Results will be reviewed by study team member and study drug will be ordered by study team if patient does not meet exclusion criteria. Study drug (IV acetaminophen or placebo) will be administered at the time of skin closure by anesthesia on completion of the surgical procedure (after randomization). Study drug will be administered every 6 hours for 2 days. Subjects will continue to receive standard of care with patient controlled analgesia (PCA) opiate therapy (morphine or hydromorphone) for analgesia as per the Pain Management Service. Pain scores, opiate (morphine equivalent) administered, requirements for treatment of opiate related side effects (treatment for nausea and itching), and certain post-operative characteristics will be measured for up to 4 days post-operatively (time to mobilization, time to diet advancement, time to discharge).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Intravenous Acetaminophen
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01394718
The ClinicalTrials.gov registry entry for NCT01394718 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (75% lower). The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01394718 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01394718 about?
NCT01394718 is a clinical study titled "Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients". This is a prospective, randomized, double-blinded, placebo controlled trial Potential subjects will be identified from the Pre-Surgical Anesthesia Clinic visit. Parents/legal guardians will be approached about study participation at the Anesthesia outpatient pre-visit. Attending Anesthesiologist wil...
What is the current status of trial NCT01394718?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2011-07. Estimated completion is 2015-07.
What conditions does trial NCT01394718 study?
This clinical trial studies the following conditions: Pain, Postoperative.
What interventions are being tested in trial NCT01394718?
The interventions under investigation include: Placebo (OTHER), Intravenous Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT01394718?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01394718 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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