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NCT00187135 · ClinicalTrials.gov registry record · Phase 3
Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration
A Phase 3 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 3
- Development phase
- 168
- Enrollment target
NCT00187135: Clinical Trial Phase 3 study, sponsored by St. Jude Children's Research Hospital.
NCT00187135 is a Phase 3 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 168 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00187135, a Phase 3 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 168 participants
- Enrollment target
Study Summary
St. Jude Children's Research Hospital is studying the best ways to prevent pain during and after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics (medicines that help people sleep) and analgesics (medicines that relieve pain). Researchers believe that a combination of fentanyl (analgesic) and propofol (anesthetic), along with applying the skin-numbing-cream EMLA or L.M.X4™ on the area where the procedure is performed, will provide better pain control. Each patient enrolled on this study will have three different anesthetic combinations for three different procedures, in order to determine which combination worked best for each child.
Primary Outcome
During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score \>0 was coded "pain", and score of 0 was coded "no pain", y
Interventions
- DRUG Propofol
- DRUG Fentanyl
- DRUG EMLA
- DRUG L.M.X4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2002-03 |
| Est. Completion | 2008-08 |
| Phase | Phase 3 |
Why NCT00187135 stopped before completion
NCT00187135 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which Propofol is the first listed.
NCT00187135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00187135 about?
NCT00187135 is a clinical study titled "Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration". St. Jude Children's Research Hospital is studying the best ways to prevent pain during and after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics (medicines that help p...
What is the current status of trial NCT00187135?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 168 participants. The study started on 2002-03. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00187135?
The interventions under investigation include: Propofol (DRUG), Fentanyl (DRUG), EMLA (DRUG), L.M.X4 (DRUG).
Who is sponsoring clinical trial NCT00187135?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00187135's enrollment target sits among peer trials
168 1459th of 2000 higher than 538 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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