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

NCT ID: NCT05848531

Last Updated: 2023-05-08

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-25

Study Completion Date

2024-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Blinded, randomised, prospective
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Unmarked bags of products, randomised before administration.

Study Groups

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Morphine

Standard Morphine PCIA

Group Type NO_INTERVENTION

No interventions assigned to this group

Clonidine and Morphine

Morphine Associated with Clonidine PCIA

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

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

Interventions

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Clonidine

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

Intervention Type DRUG

Other Intervention Names

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Catapressan

Eligibility Criteria

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Inclusion Criteria

* Vaso-Occlusive Crisis In Sickle Cell disease Patients

Exclusion Criteria

* Minor
* Patient's refusal
* Pregnancy
* Contr-indication Clonidine therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role lead

Responsible Party

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Lara Chow Yuen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU Saint-Pierre

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Lara Chow Yuen, MD

Role: primary

025353091

Andrea Carini, MD

Role: backup

025354250

References

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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.

Reference Type BACKGROUND
PMID: 35386424 (View on PubMed)

Other Identifiers

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B0762023230104

Identifier Type: -

Identifier Source: org_study_id

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