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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002180-16 | EudraCT Number |
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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 secondary objectives of this study are to compare the two study arms in terms of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care (MEOPA) | Active Comparator | Patients randomized to this arm will receive usual care, including MEOPA inhalation during local anesthetic injection and suturing. Intervention: Use of MEOPA during suturing Intervention: Stitch removal |
|
| Experimental arm (Hypnosis) | Experimental | Patients randomized to this arm will receive usual care as in the other arm, but before MEOPA inhalation is started, hypnosis will be tried. The local anesthetic injection and suturing will therefore take place under hypnosis (and MEOPA if necessary). Intervention: Use of Hypnosis during suturing Intervention: Stitch removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of MEOPA during suturing | Drug | Patients randomized to this arm will receive usual care, including MEOPA inhalation during local anesthetic injection and suturing of a wound. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Failure of pain control: yes/no | Failure of pain control as defined by:
| baseline (day 0) |
| The FLACC score | day 0, during anesthetic injection |
| Measure | Description | Time Frame |
|---|---|---|
| Pain as measured via a VAS score for children over six years of age | Score varying from 0.0 to 10.0 | day 0, during anesthetic injection |
| The EVENDOL score | day 0, during anesthetic injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Fournier, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D014949 | Wounds, Nonpenetrating |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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|
| Use of Hypnosis during suturing | Other | Patients randomized to this arm will receive usual care as in the other arm, but before MEOPA inhalation is started, hypnosis will be tried. The local anesthetic injection and suturing of the wound will therefore take place under hypnosis (and MEOPA if necessary). |
|
| Stitch removal | Procedure | 6 to 15 days after the initial suturing, stitches will be removed according to usual procedures. |
|
| time lapsed between the beginning of the procedure and end of the suture | Beginning of procedure: defined as either the beginning of MEOPA administration, or the beginning of hypnosis End of suture: the suture is declared as finished after cleaning the sutured zone, removal of drapes and placement of wound dressing | day 0 |
| time lapsed between the beginning of the procedure and the beginning of the suture | Beginning of procedure: defined as either the beginning of MEOPA administration, or the beginning of hypnosis Beginning of the suture: defined as the beginning of the first stitch | day 0 |
| MEOPA use | measured as litres/minute x minutes of administration | day 0 |
| Qualitative scale for general suturing conditions | classified as verg good, good, correct, or bad | day 0 |
| Use of physical restraint? yes/no | day 0 |
| Procedure failure: yes/non | i..e, was it necessary to resort to complementary means in order to perform the suture? | day 0 |
| Visual analog scale for operator satisfaction in relation to the performed procedure | day 0 |
| Visual analog scale for operator's perception of the ease of the procedure | day 0 |
| Visual analog scale for parental satisfaction concerning pain care and comfort during suturing | Only one VAS per child | day 0 |
| Visual analog scale for pain (only for children over 6) | during stitch removal (days 6 to 15) |
| The EVENDOL scale for pain | during stitch removal (days 6 to 15) |
| The FLACC scale for pain | during stitch removal (days 6 to 15) |
| Visual analog scale for operator's perception of the ease of stich removal | during stitch removal (days 6 to 15) |
| the child's behaviour during stitch removal | classified as: calm; afraid but capable of self-control; complementary means required | during stitch removal (days 6 to 15) |
| The presence/absence of complications | The presence/absence of at least one of the following complications: vomiting, nausea, agitation, imbalance problems, headache, persistant anesthesia at the end of the procedure. | day 0 |