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

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status

Not yet enrolling

Conditions

Pain

Treatments

Other: routine clinical treatment of pain with paracetamol or ibuprofen

Study type

Observational

Funder types

Other

Identifiers

NCT06235320
PIS-PaB

Details and patient eligibility

About

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.

Enrollment

72 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

72 participants in 2 patient groups

Paracetamol group
Treatment:
Other: routine clinical treatment of pain with paracetamol or ibuprofen
Ibuprofen group
Treatment:
Other: routine clinical treatment of pain with paracetamol or ibuprofen

Trial contacts and locations

0

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Central trial contact

Engi Algharably, PhD

Data sourced from clinicaltrials.gov

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