Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-25 @ 7:02 PM
Study NCT ID:
NCT02420002
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2015-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Emergency Suture Care: a Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Study Overview
Official Title:
Suture Care in the Pediatric Emergency Department: a Randomized Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hypno-Mo
Brief Summary:
This is a therapeutic, randomized, single center, two parallel-arm trial comparing pain control via "MEOPA" (equimolar mixture of nitrous oxide and oxygen) in one arm versus "Hypnosis + MEOPA if needed" in the second arm.
The primary objective is to compare the two study arms in terms of efficacity for pain control according to the FLACC (Face Legs Activity Cry Consolability Observational Tool) behavioural scale.
The primary objective is to compare the two study arms in terms of efficacity for pain control according to the FLACC (Face Legs Activity Cry Consolability Observational Tool) behavioural scale.
Detailed Description:
The secondary objectives of this study are to compare the two study arms in terms of:
* Efficacity for pain relief during suturing according to other validated scales (a visual analog scale (VAS), the EVENDOL (Evaluation Enfant Douleur) scale);
* the duration of the procedure, the time between the start of the care process for pain (hypnosis or nitrous oxide) and the beginning of the suture;
* the amount of nitrous oxide administered;
* the conditions under which suturing takes place, in terms of (i) the general conditions of implementation, (ii) the need to use physical restraint, (iii) failure of the procedure and the need to resort to supplementary means of anesthesia, (iv) satisfaction of the operator and his/her perceived ease of operations, (v) satisfaction of the parents;
* the behavior of the patient during removal of the suture;
* the conditions under which suture removal takes place;
* complications related to the used treatments.
* Efficacity for pain relief during suturing according to other validated scales (a visual analog scale (VAS), the EVENDOL (Evaluation Enfant Douleur) scale);
* the duration of the procedure, the time between the start of the care process for pain (hypnosis or nitrous oxide) and the beginning of the suture;
* the amount of nitrous oxide administered;
* the conditions under which suturing takes place, in terms of (i) the general conditions of implementation, (ii) the need to use physical restraint, (iii) failure of the procedure and the need to resort to supplementary means of anesthesia, (iv) satisfaction of the operator and his/her perceived ease of operations, (v) satisfaction of the parents;
* the behavior of the patient during removal of the suture;
* the conditions under which suture removal takes place;
* complications related to the used treatments.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-002180-16 | EUDRACT_NUMBER | None | View |