A Phase 3 interventional study of Lidocaine = group A and Group B placebo in Undernutrition, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 3, Interventional, and Treatment
Enteral nutrition is the treatment of choice for malnourish patient. Nasogastric tube (NGT) is although a common act. Unfortunately, this procedure can be painful. Also, many patients will need many NGT re-insertion. Therefore, the investigators need to increase the acceptability of this procedure by increasing comfort during NGT passage. Professionals guidelines of HAS (recommendations professionnelles de bonne pratiques de soins) and SFNEP (Société Française de Nutrition Clinique et Métabolisme) talk about the possibility of using local anesthesic without ordering their use. However, NGT tube insertion is often put without pre-medication in the face of an accumulating body of evidence indicating that local anesthetic prior NGT insertion decrease discomfort of the procedure. On the other hand, these studies have been done in the emergency room with NGT of a bigger gauge and for many reasons except enteral nutrition.
The investigators primary objective of this prospective monocentric study is to evaluate the efficacy (patient comfort) of lidocaine 5 % spray versus placebo (physiologic serum) before NGT insertion in patient needing enteral nutrition, using visual analogue scale. Secondary objectives are to evaluate nurse and patient satisfaction using questionnaires, facility of NGT insertion using Likert scale, numbers of try, time of procedure, complications like tracheal insertion and success of the insertion using thorax x-ray.
The study will be held in CHU Nice at nutrition unit support. After signed consentment, patients will be separate in two groups : group A (lidocaïne spray 5 %) and group B (physiologic serum). There will be 2 spray in nostril and 2 in orophagyngeal cavity 2 minutes before NGT insertion, which will be done by a competent nurse. Vital signs will be noted at the beginning of the procedure and 10 minutes after. At the end, the nurse and the patient will have to answer a questionnaire. Pain will be grade using visual analogue scale immediately after the procedure. Demographic data and complications will be note by the investigator. Finally, thorax X-ray will be done at the end of the procedure. There will be 34 patients by group. If the investigators find a benefit, this can change their practice and guidelines.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 61 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.
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Exclusion Criteria
patient nécessitant une SNG pour nutrition entérale bénéficiant d'une pré-médication par vaporisateur de lidocaïne lors de l'insertion (group A = lidcoaine)
Drug: Lidocaine = group A
Patient requiring a SNG for nutrition entérale benefiting from a pre-medication by placebo during the insertion (group B)
Drug: Group B placebo
Patient requiring a SNG for nutrition entérale benefiting from a pre-medication by spray of lidocaïne during the insertion (group A = lidocaine)
Patient requiring a SNG for nutrition entérale benefiting from a pre-medication by placebo during the insertion
EVA
Pain and comfort during NGT insertion will be evaluate using visual analogue scale (0 to 100 mm marqued at each side: extreme pain and no pain).
Time frame: one time
Scales
* Nurse satisfaction using Likert scale from 1 to 5 * Patient satisfaction using Likert scale from 1 to 5 * Facility of NGT insertion using Likert scale from 1 to 5 and numbers of try: defined by numbers of insertions necessary by 1 operator. * Tolerance of the procedure: all complications will be note from beginning until 20 minutes. * Time for the NGT insertion defined like the number of minutes between the first attempt (when the nurse take the tube) until the end of the procedure. * Success of the insertion, defined by good insertion confirmed by an X-ray and procedure done by one operator.
Time frame: one time
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice