MedTrace Logo

The IM-ZBULLE Study : " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol Decanoate

NCT05995457 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-08-23

No results posted yet for this study

Summary

Intramuscular injection (IMI) is the process of administering a drug treatment into muscle tissue. The transmission of skills in this care practice is essentially based on the experience of peers. In France, there are no official guidelines for this technical procedure.

Haloperidol decanoate is widely used in psychiatry. This long-acting antipsychotic treatment considerably reduces the risk of relapse and hospitalization. It is administered by IMI. This treatment is invasive, painful and risks complications for the patient. Nurses must ensure that the treatment is as painless as possible, and adapt their practice in line with current recommendations.

Among the various IMI techniques available, the "Z-track" and the "Airlock" limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues. According to an exploratory study (n=303), 73% of nurses observe active product leakage after injections, and 89% of nurses are not familiar with either the "Z-track" or "Airlock" techniques.

Many foreign studies have been carried out to demonstrate the relevance of these techniques, particularly in terms of pain reduction during treatment, but the results have yet to be confirmed.

The investigators hypothesize that the combined use of the "Z-track" and "Airlock" techniques during intramuscular injection of Haloperidol decanoate is more effective in reducing patient pain than usual practice.

Conditions

  • Schizophrenia; Psychosis

Interventions

OTHER

Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniques

Intramuscular injection involves administering the drug treatment Haloperidol decanoate into muscle tissue using the "Z-track" and "Airlock" techniques

OTHER

Intramuscular injection of Haloperidol decanoate using standard techniques

Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique.

Sponsors & Collaborators

  • Groupe Hospitalier Paul Guiraud

    collaborator UNKNOWN

  • Etablissement Public de Santé Barthélemy Durand

    collaborator OTHER

  • Centre Hospitalier St Anne

    lead OTHER

Principal Investigators

  • Rayan BCHINI · GHU Paris Psychiatry & Neurosciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-09-30
Completion
2024-11-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05995457 on ClinicalTrials.gov