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Paracetamol Effect on Prostaglandins and Blood Pressure

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06235320
Acronym
PIS-PaB
Enrollment
72
Registered
2024-01-31
Start date
2025-03-01
Completion date
2026-09-01
Last updated
2025-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

OTHERroutine clinical treatment of pain with paracetamol or ibuprofen

No intervention beside clinical routine management

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prostanoid levelsjust before treatment and 24 hours after treatment with paracetamol or ibuprofenA 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

MeasureTime frameDescription
Blood pressurejust before treatment and 24 hours after treatment with paracetamol or ibuprofenAutomated office and ambulatory blood pressure measurement

Contacts

Primary ContactEngi Algharably, PhD
engi.algharably@charite.de030/ 450 525 221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026