Clinical TrialID 6096
Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
NCT03090620
Anticholinergics Toxicity
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6096
- Evidence Id
- 6096
- Core Evidence Id
- 6096
- Source Clinical Trial Id
- 6078
- Herb2 Clinical Trial Id
- HBCT006078
- Nct Id
- NCT03090620
- Title
- Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
- Status
- Completed
- Phase
- Phase 4
- Study Result
- Yes
- Study Condition
- Anticholinergics Toxicity
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Physostigmine|DRUG: Lorazepam
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child
- Enrollment
- 19
- Outcome Measure
- Comparison of RASS Score Between Physostigmine and Lorazepam: Before Bolus, Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert \& calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement., Baseline, immediately before bolus|Comparison of RASS Score Between Physostigmine and Lorazepam: After Bolus, Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert \& calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement., Immediately after bolus, up to 10 minutes post-Baseline|Comparison of RASS Score Between Physostigmine and Lorazepam: 4 Hours, Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert \& calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement., 4 hours|Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: Before Bolus, Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome ("yes" or "no" for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported., Baseline, immediately before bolus|Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: After Bolus, Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome ("yes" or "no" for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported., Immediately after bolus, up to 10 minutes post-Baseline|Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: 4 Hours, Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome ("yes" or "no" for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported., 4 hours
- Sponsor Collaborator
- University of Colorado, Denver|American Academy of Clinical Toxicology
- Funded By
- OTHER
- Location
- University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora, Colorado, 80045, United States
- Other Id
- 16-1730
- Start Date
- 2017-03-30
- Primary Completion Date
- 2020-07-31
- Completion Date
- 2020-08-31
- First Posted
- 2017-03-27
- Results First Posted
- 2021-08-23
- Last Update Posted
- 2021-08-23
- Study Document
- Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/20/NCT03090620/Prot_SAP_000.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT03090620
- Title Cn
- Title En
- Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
- Bilingual Status
- semi_complete