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Phase 4 N=5 Randomized Treatment

Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy

Overdose

Enrolled (actual)
5
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Absorption of Acetaminophen as Indicated by Area Under the Curve — 3566; 3335 mcg*min/mL

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Activated Charcoal (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
State University of New York - Upstate Medical University
Primary completion
Mar 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Absorption of Acetaminophen as Indicated by Area Under the Curve
3566; 3335
PRIMARY
Maximum Concentration Acetaminophen
33; 29
PRIMARY
Time to Maximum Concentration of Acetaminophen
51; 66
SECONDARY
Appeal of Charcoal Mixture
4.6; 2.8
SECONDARY
Smell of Charcoal Mixture
5.8; 6.4
SECONDARY
Flavor of Charcoal Mixture
5.8; 3.0
SECONDARY
Texture of Charcoal Mixture
4.4; 2.8
SECONDARY
Overall Appeal of Charcoal Mixture
4.4; 3.2

Summary

Activated charcoal (AC) is an established, effective means of gastrointestinal decontamination. Providers give it to patients who have ingested something that is thought to be potentially poisonous to prevent it from being absorbed. However, one limitation to its use is palatability of the AC for the patient, potentially limiting how much, if any, is taken. Other studies have suggested that mixing AC with various substances improves the rating on various scales (taste, etc). An important question is whether mixing the AC with other substance effects the ability of the AC to bind to xenobiotic in the gut. This small study investigates whether mixed cola with charcoal affected its ability to prevent the absorption of acetaminophen. It also performs a survery to see if participants preferred the AC-cola mixture. The investigators hypothesize that the AC will be equally as effective with cola as without. The investigators also hypothesize that participants will prefer the AC-cola mixture.

Eligibility Criteria

Inclusion Criteria

  • No self-reported history of any hepatic, gastrointestinal, or renal disease
  • No self-reported history of alcohol or substance use disorder
  • No daily prescribed medications
  • Weight between 60-93 kg

Exclusion Criteria

  • pregnant,
  • imprisoned
  • allergy or intolerance to acetaminophen or gluten
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06219967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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