Attention and Memory Disorders Related to Acute Morphine

NCT03507985 | Unknown

• 2 other identifiers: RC31/18/01442018-A00991-54
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine if there are attention disorders related to acute morphine use in single-traumatized patients and after that the investigators will determine whether there are immediate memory problems associated with acute morphine withdrawal in single-traumatized patients. From a biochemical point of view, the analgesic effects of morphine and the central side effects appear to be two different dimensions of the action of morphine, each related to a metabolite. Regarding acute attention, it is difficult to differentiate attention deficit disorder due to pain or due to morphine. Two tests have been validated in the literature to evaluate attention and memory: the 15 words of Rey and the Stroop Color Word test. The investigators will use these two tests in this study.

Conditions

Memory Disorders

Keywords

morphine; attention disorders

Outcome Measures

Primary Outcomes (1)

• The comparison of acute attention deficit according to the exposed or unexposed patient.

  The primary endpoint selected is the comparison of acute attention deficit according to the exposed or unexposed patient. For each patient, the investigators will calculate the percentage of deficit between the Stroop Color Word test result at inclusion and at follow-up divided by the tracking score. This acute deficit is expressed as a percentage. The primary endpoint selected is the comparison of acute attention deficit according to the exposed or unexposed patient.

  1 month

Secondary Outcomes (1)

• The comparison of the acute memory deficit according to the exposed or unexposed nature of the patient

  1 month

Study Arms (2)

The exposed group

The exposed group where patients receive morphine analgesia The patient will realise two tests evaluating memory and attention, for the first at the inclusion visit after giving his consent, and in a second time during the follow up visit 15 days or 1 month later.

Other: Two tests evaluating memory and attention

The unexposed group

The unexposed group where patients receive 1 +/- 2-stage analgesia is non-opioid analgesics. The patient will realise two tests evaluating memory and attention, for the first at the inclusion visit after giving his consent, and in a second time during the follow up visit 15 days or 1 month later.

Other: Two tests evaluating memory and attention

Interventions

Two tests evaluating memory and attention OTHER

The patient will perform two tests assessing memory and attention: Regarding attention, the test used will be the Stroop Color Word Test, developed to measure visual selective attention, cognitive flexibility and inhibition. For memory, the test used will be Rey's 15 words test. It provides an indicative standard for the evaluation of episodic verbal memory and learning abilities. This test was compared to the 16-item (18) free recall / booster test in normal aging and Alzheimer's dementia, and although it was more difficult, it . Since it allowed for the classification of participants from both groups without overlap

The exposed group; The unexposed group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two groups of patients : The exposed group where patients receive morphine analgesia The unexposed group where patients receive stage 1 +/- 2 analgesia is non-opioid analgesics.

You may qualify if:

• Patients over 18
• Mono traumatized (suspicion of bone fracture) without vital distress, neurological, cardio-circulatory or pulmonary involvement
• Analgesia obtained, defined by a pain score on a numerical scale ≤ 3/10 at the end of the treatment
• Patients presenting in an emergency department of Toulouse University Hospital

You may not qualify if:

• Patients with vital distress, whatever the cause,
• Traumatized cranial,
• pre-existing labeled attention disorders (eg, diagnosed hyperactivity),
• Pre-existing memory disorders labeled (eg, dementia)
• Use of opioid analgesics other than morphine in the care of these patients
• Chronic opiate users (licit or illicit)
• Psychiatric disorders
• Acute alcohol poisoning, voluntary drug poisoning or not, acute intoxication by drugs
• Visual disorders (colorblind ..), patients who can not read

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Memory Disorders; Cognition Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Vincent Bounes, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Bounes, MD

CONTACT

05 67 69 16 76; bounes.v@chu-toulouse.fr

Isabelle Olivier, PhD

CONTACT

05 61 77 70 51; olivier.i@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: April 25, 2018
• Study Start: September 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)