Paracetamol Effect on Prostaglandins and Blood Pressure (PIS-PaB)

February 24, 2025 updated by: Engi Algharably, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The first cohort consists of patients of the headache consultation at Charité Campus Mitte, where data is collected both within and outside of clinical routine, whereby the medical care of the respective patients takes place in the usual routine.

The second cohort consists of patients attending oral surgery consultations at the Institute of Dentistry, Oral and Maxillofacial Surgery, for whom data is also collected both within and outside of clinical routine, whereby the medical care of the respective patients takes place in the usual routine.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Paracetamol group
Other: routine clinical treatment of pain with paracetamol or ibuprofen
No intervention beside clinical routine management
Ibuprofen group
Other: routine clinical treatment of pain with paracetamol or ibuprofen
No intervention beside clinical routine management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
just before treatment and 24 hours after treatment with paracetamol or ibuprofen

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: just before treatment and 24 hours after treatment with paracetamol or ibuprofen
Automated office and ambulatory blood pressure measurement
just before treatment and 24 hours after treatment with paracetamol or ibuprofen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIS-PaB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual patient data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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