Clonidine With Morphine in Patient Controlled Analgesia Pump in Vaso-Occlusive Crisis in Sickle Cell Disease Patient

Sickle Cell Disease Clinical Trial

Official title:

Advantage of Clonidine With Morphine In Patient Controlled Analgesia Pump for the Treatment of Vaso-occlusive Crisis in Sickle Cell Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848531
• Other study ID #: B0762023230104
• Status: Recruiting
• Phase: Phase 4
• Start date: April 25, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vaso-occlusive crisis are highly painful in Sickle-cell patients. Morphine is the treatment of choice for this pain. Various adjuncts have been studied for the treatment of vaso-occlusive crisis.

The investigators aimed to study the effect of clonidine associated with morphine in PCIA (patient controlled intravenous analgesia pumps) regimen. The investigators will compare it to the morphine alone in PCIA for the treatment of vaso-occlusive pain.

The investigators will measure the morphine consumption of all patient, the impact on the apparition of the morphine secondary effect and on inflammation biomarkers and the biopsychosocial respond.

Each patient will be hospitalized and follow by haematologist from the hospital, pain doctors and nurses.

It will be a double blind randomised, prospective study. The randomisation will be done by the pharmacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 28, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Vaso-Occlusive Crisis In Sickle Cell disease Patients

Exclusion Criteria:

• Minor

• Patient's refusal

• Pregnancy

• Contr-indication Clonidine therapy

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease
• Vaso-occlusive Pain Episode in Sickle Cell Disease

Intervention

Drug:
• Clonidine
Comparing Clonidine with Morphine PCIA for the treatment of Vaso-Occlusive crisis in Sickle Cell disease patient

Locations

Country	Name	City	State
Belgium	CHU Saint-Pierre	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Kenney MO, Smith WR. Moving Toward a Multimodal Analgesic Regimen for Acute Sickle Cell Pain with Non-Opioid Analgesic Adjuncts: A Narrative Review. J Pain Res. 2022 Mar 31;15:879-894. doi: 10.2147/JPR.S343069. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Consumption	Morphine Consumption during hospitalisation	Up to two weeks
Secondary	Numerical Rating Scale	Pain Score scale from 0 to ten during and after treatment	Up to two weeks
Secondary	Biology markers	Inflammatory biology markers (CRP,IL-6) and Hemolysis (LDH)	Up to two weeks
Secondary	Biopsychosocial model / ASCQ-ME questionary	Evaluation of the biopsychosocial model. There are seven different themes of 4 to 7 questions each (pain intensity, pain episodes, sleep impact, social impact, emotional impact, medical history and stiffness)	Up to two weeks