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Analgesic

Acetaminophen/APAP for Pain

Phase 2 & 3

Waitlist Available

Led By John N van den Anker, MD, PhD

Research Sponsored by John van den Anker

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

Study Summary

This trial will investigate how acetaminophen is broken down and released into urine and blood in preterm infants. It will also look at how different genes or characteristics affect how acetaminophen is processed in these infants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

primary endpoint PK analysis

Secondary outcome measures

Developmental stage

Trial Design

1Treatment groups

Experimental Treatment

Group I: group 2 Pain managementExperimental Treatment1 Intervention

In preterm and term neonates with a GA of 28 weeks or more a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute. In preterm and term neonates with a GA of less than 28 weeks 15 mg/kg dose of APAP will be given every 12 hrs by an intravenous infusion over 30-minute

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Who is running the clinical trial?

John van den AnkerLead Sponsor

2 Previous Clinical Trials

93 Total Patients Enrolled

John N van den Anker, MD, PhDPrincipal InvestigatorChildren's National Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project only include young adults?

"To be eligible for this clinical trial, applicants must fall between the age of 22 weeks and 37 weeks. There are 110 other studies available for people under 18 years old and 321 for senior citizens."

Answered by AI

What are the qualifying factors to participate in this clinical trial?

"This study is recruiting 31 participants that experience pain and falls between the ages of 22 to 37 weeks."

Answered by AI

For what purpose is Acetaminophen/APAP most commonly prescribed?

"Acetaminophen/APAP is most typically used to treat catarrh but can also be applied to mitigate the symptoms of rhinorrhoea, musculoskeletal pain, and muscle spasms."

Answered by AI

Does this research on Acetaminophen stand alone or build upon past investigations?

"As of right now, there are 98 trials researching the efficacy of Acetaminophen/APAP. Of those 29 live clinical trials are in Phase 3. However, 1008 locations across the world are running studies for this potential treatment."

Answered by AI

How many individuals are included in the scope of this research project?

"This study has concluded patient recruitment. The trial was posted on October 1st, 2011 and updated for the last time on March 1st, 2022. However, there are many other studies still recruiting; For example, currently 364 trials concerning pain and 98 involving Acetaminophen/APAP are ongoing."

Answered by AI

Recent research and studies

Clinical PharmacokineticsJournal

Neonatal Maturation of Paracetamol (acetaminophen) Glucuronidation, Sulfation, and Oxidation Based on a Parent–metabolite Population Pharmacokinetic Model

Cook, Sarah F., Chris Stockmann, Samira Samiee-Zafarghandy, Amber D. King, Nina Deutsch, Elaine F. Williams, Diana G. Wilkins, Catherine M. T. Sherwin, and John N. van den Anker. 2016. “Neonatal Maturation of Paracetamol (acetaminophen) Glucuronidation, Sulfation, and Oxidation Based on a Parent–metabolite Population Pharmacokinetic Model”. Clinical Pharmacokinetics. Springer Science and Business Media LLC. doi:10.1007/s40262-016-0408-1.

Journal of Chromatography BJournal

Simultaneous Quantification of Acetaminophen and Five Acetaminophen Metabolites in Human Plasma and Urine by High-performance Liquid Chromatography–electrospray Ionization–tandem Mass Spectrometry: Method Validation and Application to a Neonatal Pharmacokinetic Study

Cook, Sarah F., Amber D. King, John N. van den Anker, and Diana G. Wilkins. 2015. “Simultaneous Quantification of Acetaminophen and Five Acetaminophen Metabolites in Human Plasma and Urine by High-performance Liquid Chromatography–electrospray Ionization–tandem Mass Spectrometry: Method Validation and Application to a Neonatal Pharmacokinetic Study”. Journal of Chromatography B. Elsevier BV. doi:10.1016/j.jchromb.2015.10.013.

Clinical PharmacokineticsJournal

Population Pharmacokinetics of Intravenous Paracetamol (acetaminophen) in Preterm and Term Neonates: Model Development and External Evaluation

Cook, Sarah F., Jessica K. Roberts, Samira Samiee-Zafarghandy, Chris Stockmann, Amber D. King, Nina Deutsch, Elaine F. Williams, et al.. 2015. “Population Pharmacokinetics of Intravenous Paracetamol (acetaminophen) in Preterm and Term Neonates: Model Development and External Evaluation”. Clinical Pharmacokinetics. Springer Science and Business Media LLC. doi:10.1007/s40262-015-0301-3.

clinicaltrials.govStudy