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

Primary Purpose

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

Status

Recruiting

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Clonidine

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring Clonidine, Morphine, Acute Pain management, patient controlled analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Vaso-Occlusive Crisis In Sickle Cell disease Patients Exclusion Criteria: Minor Patient's refusal Pregnancy Contr-indication Clonidine therapy

Sites / Locations

CHU Saint-PierreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Morphine

Clonidine and Morphine

Arm Description

Standard Morphine PCIA

Morphine Associated with Clonidine PCIA

Outcomes

Primary Outcome Measures

Morphine Consumption

Morphine Consumption during hospitalisation

Secondary Outcome Measures

Numerical Rating Scale

Pain Score scale from 0 to ten during and after treatment

Biology markers

Inflammatory biology markers (CRP,IL-6) and Hemolysis (LDH)

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)

Full Information

NCT ID

NCT05848531

First Posted

March 30, 2023

Last Updated

May 5, 2023

Sponsor

Centre Hospitalier Universitaire Saint Pierre

1. Study Identification

Unique Protocol Identification Number

NCT05848531

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 25, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Clonidine, Morphine, Acute Pain management, patient controlled analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Double Blinded, randomised, prospective

Masking

ParticipantCare ProviderInvestigator

Masking Description

Unmarked bags of products, randomised before administration.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Morphine

Arm Type

No Intervention

Arm Description

Standard Morphine PCIA

Arm Title

Clonidine and Morphine

Arm Type

Experimental

Arm Description

Morphine Associated with Clonidine PCIA

Intervention Type

Drug

Intervention Name(s)

Clonidine

Other Intervention Name(s)

Catapressan

Intervention Description

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

Primary Outcome Measure Information:

Title

Morphine Consumption

Description

Morphine Consumption during hospitalisation

Time Frame

Up to two weeks

Secondary Outcome Measure Information:

Title

Numerical Rating Scale

Description

Pain Score scale from 0 to ten during and after treatment

Time Frame

Up to two weeks

Title

Biology markers

Description

Inflammatory biology markers (CRP,IL-6) and Hemolysis (LDH)

Time Frame

Up to two weeks

Title

Biopsychosocial model / ASCQ-ME questionary

Description

Time Frame

Up to two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Vaso-Occlusive Crisis In Sickle Cell disease Patients Exclusion Criteria: Minor Patient's refusal Pregnancy Contr-indication Clonidine therapy

Facility Information:

Facility Name

CHU Saint-Pierre

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact: