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

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: Pain
• Intervention / Treatment: Other: routine clinical treatment of pain with paracetamol or ibuprofen

• Study Type: Observational
• Enrollment (Estimated): 72

Contacts and Locations

• Study Contact: Name: Engi Algharably, PhD; Phone Number: 030/ 450 525 221; Email: engi.algharably@charite.de

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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	Automated office and ambulatory blood pressure measurement	just before treatment and 24 hours after treatment with paracetamol or ibuprofen

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 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): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• 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