Paracetamol Effect on Prostaglandins and Blood Pressure

NCT06235320 | Not Yet Recruiting

• 1 other identifier: PIS-PaB
• Study Type: observational
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood pressure

  just before treatment and 24 hours after treatment with paracetamol or ibuprofen

Study Arms (2)

Paracetamol group

Other: routine clinical treatment of pain with paracetamol or ibuprofen

Ibuprofen group

Other: routine clinical treatment of pain with paracetamol or ibuprofen

Interventions

routine clinical treatment of pain with paracetamol or ibuprofen OTHER

No intervention beside clinical routine management

Ibuprofen group; Paracetamol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and urine

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Central Study Contacts

Engi Algharably, PhD

CONTACT

030/ 450 525 221; engi.algharably@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 31, 2024
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 26, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share