Paracetamol Effect on Prostaglandins and Blood Pressure

Not yet recruiting

• Conditions: Pain
• Interventions: Other: routine clinical treatment of pain with paracetamol or ibuprofen

• Registration Number: NCT06235320
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Study Start: 2025-03-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ibuprofen group	routine clinical treatment of pain with paracetamol or ibuprofen	-
Paracetamol group	routine clinical treatment of pain with paracetamol or ibuprofen	-

Primary Outcome Measures

Name	Time	Method
Prostanoid levels	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 Outcome Measures

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