Paracetamol Effect on Prostaglandins and Blood Pressure

NCT ID: NCT06235320

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-09-01

Brief Summary

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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

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Conditions

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Paracetamol group

routine clinical treatment of pain with paracetamol or ibuprofen

Intervention Type OTHER

No intervention beside clinical routine management

Ibuprofen group

routine clinical treatment of pain with paracetamol or ibuprofen

Intervention Type OTHER

No intervention beside clinical routine management

Interventions

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routine clinical treatment of pain with paracetamol or ibuprofen

No intervention beside clinical routine management

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Engi Algharably

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Engi Algharably, PhD

Role: CONTACT

030/ 450 525 221

Other Identifiers

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PIS-PaB

Identifier Type: -

Identifier Source: org_study_id

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