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NCT06235320 Clinical Trial

Paracetamol Effect on Prostaglandins and Blood Pressure

Pain Clinical Trial

— PIS-PaB  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06235320
Other study ID # PIS-PaB
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date March 1, 2026

Study information
Verified date February 2024
Source Charite University, Berlin, Germany
Contact Engi Algharably, PhD
Phone 030/ 450 525 221
Email engi.algharably@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 72
Est. completion date March 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• routine clinical treatment of pain with paracetamol or ibuprofen
No intervention beside clinical routine management

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Blood pressure Automated office and ambulatory blood pressure measurement just before treatment and 24 hours after treatment with paracetamol or ibuprofen
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