Comparative Study Between Levobupivacaine and Bupivacaine for Nerve Block During Pediatric Primary Cleft Palate Surgery
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 13% of the time (1,012 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-10-31, 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 2016-10-31. 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: injurycareassociatedblockthe risk
Phrases that lowered it: nasalgoodgeneraluppercombination -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Primary purpose: prevention (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 87 (lowers risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 8.9% (lowers risk) · Drug's FDA history
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Minimum age: 1 (lowers risk) · Who can join
-
Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Phase: 2/3 (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Blinding: double (raises risk) · Design
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Drug's FAERS reports before start: 5095 (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 88.3% (raises risk) · Drug's FDA history
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Maximum age: 10 (raises risk) · Who can join
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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- double (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
- 1 (typical: 18)
- Maximum age
- 10 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 41 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 87 (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
- 5095 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 704 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- musculoskeletal
- Drugs matched to FDA substances
- bupivacaine, levobupivacaine
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
- Suprazygomatic Block in Cleft Palate Surgery in Children NCT03412474 · started 2018 · scored riskier than 10% of active trials completed
- Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery. NCT02514980 · started 2015 · scored riskier than 11% of active trials completed
- Nalbuphine as Adjuvant During Bilateral Suprazygomatic Maxillary Nerve Block for Pediatric Cleft Palate Repair NCT06100315 · started 2023 · scored riskier than 4% of active trials completed
- Does it Worth to Reinforce With Additional Anesthesia to Improve Postoperative Course After Orthognathic Surgery? NCT03974035 · started 2018 · scored riskier than 19% of active trials completed
- Dexmedetomidine Versus Magnesium Sulphate Added to Bupivacaine in Infraorbital Nerve Block for Perioperative Analgesia in Paediatric Patients for Cleft Lip Surgery NCT05624151 · started 2022 · scored riskier than 11% 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.