Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,198 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-08-03, after 2023-05-18 start.
Reason given by the sponsor: “enrollment”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-08-03. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: painchronicsubjectssyndromeopioid
Phrases that lowered it: patientstrialsignstatusprovided -
Sponsor's past termination rate: 17.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Blinding: single (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Sponsor's past trials: 677 (raises risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 124 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 69.9% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 21863 (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: 11.1% (lowers risk) · Drug's FDA history
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Maximum age: 17 (raises risk) · Who can join
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Drug's FAERS reports before start: 228535 (lowers risk) · Drug's FDA history
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Minimum age: 2 (lowers risk) · Who can join
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Number of arms: 2 (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Collaborators: 0 (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Drugs with FDA adverse-event history: 2 (lowers risk) · Drug's FDA history
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 2 (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 677 (typical: 32)
- Sponsor's past termination rate
- 17.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 124 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 228535 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 21863 (typical: 412.5)
- Drug's FAERS reports marked serious
- 69.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- lidocaine, ondansetron
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department NCT02079090 · started 2014 · scored riskier than 77% of active trials completed
- A Comparison of Midazolam and Zolpidem as Oral Premedication in Children NCT02096900 · started 2014 · scored riskier than 46% of active trials completed
- A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients NCT01635101 · started 2012 · scored riskier than 42% of active trials completed
- Opioid Sparing Analgesia: Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children NCT04535089 · started 2020 · scored riskier than 7% of active trials completed
- Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection NCT03134612 · started 2016 · scored riskier than 7% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.