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NCT Number: NCT06235320

Paracetamol Effect on Prostaglandins and Blood Pressure

This research program aims to investigate the influence of paracetamol on blood pressure and the cyclooxygenase (COX) - prostaglandine (PG) pathway in patients with pain. Through an observational pilot study, we will use advanced LC/ESI-MS/MS methodology to analyze the COX-OG pathway in plasma and urine. The study will assess the effects of paracetamol compared to ibuprofen, considering different types of pain. The primary focus is to understand the changes in blood pressure and the COX-PG pathway upon initiation or discontinuation of paracetamol, with safety analysis as a secondary consideration.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Headache and orosurgical patients treated at the respective charite outpatient clinic.
  • Age 18 years or older
  • Able to consent
  • Patients with migraine type headache treated with paracetamol or ibuprofen within the last 12 hours or not treated with paracetamol or ibuprofen within the last 48 hours
  • Patients treated with with paracetamol or ibuprofen undergoing orosurgery for wisedome tooth extraction

Exclusion criteria

  • Pregnancy
  • Arterial hypertension
  • Use of beta blockers
  • Use of COX inhibitors other than paracetamol or ibuprofen, including low-dose acetylsalicylic acid
  • Stable prophylactic therapy of migraine for less than 3 weeks
  • Use of tryptans in the last two days (Frovatriptane in the last 6 days)
  • Oral surgery patients using paracetamol or ibuprofen in the last 24 hours
  • Known allergy to paracetamol or ibuprofen

Treatment and study plan

routine clinical treatment of pain with paracetamol or ibuprofen

Other

No intervention beside clinical routine management

Primary outcomes

  1. Prostanoid levels

    Time frame: just before treatment and 24 hours after treatment with paracetamol or ibuprofen

    A comprehensive lipidomic analysis measuring the levels of prostanoids in plasma and spot urine samples using liquid chromatography tandem mass spectrometry (LC/ESI-MS/MS) technology in all participants.

Secondary outcomes

  1. Blood pressure

    Time frame: just before treatment and 24 hours after treatment with paracetamol or ibuprofen

    Automated office and ambulatory blood pressure measurement

Study contacts

Contact information is provided by the study sponsor or research team.

Engi Algharably, PhD

CONTACT

[email protected]

030/ 450 525 221

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Paracetamol Impact Study: Prostaglandin Synthesis and Blood Pressure Effects (PIS-PaB)

Acronym: PIS-PaB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2024
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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