An Evaluation of Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (130 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-01-25, after 2022-11-25 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 2024-01-25. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 50% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: administrationpainundergoingmorphinevomiting
Phrases that lowered it: effectsinjectionbleedinglowersimilar -
Phase: 2 (raises risk) · Design
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Blinding: single (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: supportive care (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 982662 (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 13.6% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 73.9% (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Maximum age: 18 (raises risk) · Who can join
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Minimum age: not given (raises risk) · Who can join
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Sponsor's past trials: 4 (lowers risk) · Sponsor's track record
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Drugs with FDA adverse-event history: 5 (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 107007 (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Collaborators: 0 (raises 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- supportive care (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 18 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 4 (typical: 32)
- Sponsor's past termination rate
- 50% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 982662 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 107007 (typical: 412.5)
- Drug's FAERS reports marked serious
- 73.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- acetaminophen, bupivacaine, ibuprofen, ketorolac, sevoflurane
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
- Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision NCT02973958 · started 2017 · scored riskier than 51% of active trials completed
- Combination Analgesia for Neonatal Circumcision NCT02990364 · started 2015 · scored riskier than 10% of active trials completed
- KITS Study -Ketorolac In Tonsillectomy Surgery: a Double Blinded, Randomized Clinical Trial NCT01498796 · started 2009 · scored riskier than 69% of active trials terminated
- COMPARISON OF BUPIVACAINE WITH AND WITHOUT DEXMEDETOMIDINE IN CAUDAL BLOCK AMONG CHILDREN UNDERGOING INGUINAL HERNIOTOMY NCT07140627 · started 2024 · scored riskier than 4% of active trials completed
- Needle Procedures Success Rate After Application of Ralydan vs EMLA in Children NCT02519660 · started 2015 · scored riskier than 19% 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.