Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (741 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-02-28, after 2016-01-31 start.
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 2018-02-28. 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: injuryintravenousbrainhoursto assess
Phrases that lowered it: participantcriteria patientsvisittrialthe aim -
Sponsor's past termination rate: 11.5% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 17.1% (lowers risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 62 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 94.1% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 5 (lowers risk) · Who can join
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Maximum age: 17 (raises risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 131 (lowers risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 5 (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
- 131 (typical: 32)
- Sponsor's past termination rate
- 11.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 62 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 2260 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 408 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ketamine
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
- IN Sub-Dissociative Ketamine vs IN Fentanyl NCT02521415 · started 2015 · scored riskier than 77% of active trials completed
- Pain Reduction With Intranasal Medications for Extremity Injuries NCT02778880 · started 2016 · scored riskier than 73% of active trials completed
- Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department NCT01387139 · started 2011 · scored riskier than 22% of active trials completed
- Pain Free Laceration Repairs Using Intra-nasal Ketamine NCT03053947 · started 2017 · scored riskier than 71% of active trials completed
- Intranasal Ketamine and Fracture Reduction in Pediatric Emergencies (KETAPED) NCT03525821 · started 2018 · scored riskier than 26% 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.