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: * 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients randomized to this arm will receive usual care, including MEOPA inhalation during local anesthetic injection and suturing of a wound.
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).
6 to 15 days after the initial suturing, stitches will be removed according to usual procedures.
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
Failure of pain control: yes/no
Failure of pain control as defined by: * The conversion of the procedure to MEOPA (for the hypnosis arm) or to sedation (for the MEOPA arm. Conversion is decided if the FLACC score at the end of the induction phase of hypnosis or for MEOPA is greater than 3 (1-3 are equivalent to mild discomfort). * Or a FLACC score\> 3 during the period between anesthetic injection and the end of the suture.
Time frame: baseline (day 0)
The FLACC score
Time frame: day 0, during anesthetic injection
Pain as measured via a VAS score for children over six years of age
Score varying from 0.0 to 10.0
Time frame: day 0, during anesthetic injection
The EVENDOL score
Time frame: day 0, during anesthetic injection
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
Time frame: 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
Time frame: day 0
MEOPA use
measured as litres/minute x minutes of administration
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Time frame: day 0
Qualitative scale for general suturing conditions
classified as verg good, good, correct, or bad
Time frame: day 0
Use of physical restraint? yes/no
Time frame: day 0
Procedure failure: yes/non
i..e, was it necessary to resort to complementary means in order to perform the suture?
Time frame: day 0
Visual analog scale for operator satisfaction in relation to the performed procedure
Time frame: day 0
Visual analog scale for operator's perception of the ease of the procedure
Time frame: day 0
Visual analog scale for parental satisfaction concerning pain care and comfort during suturing
Only one VAS per child
Time frame: day 0
Visual analog scale for pain (only for children over 6)
Time frame: during stitch removal (days 6 to 15)
The EVENDOL scale for pain
Time frame: during stitch removal (days 6 to 15)
The FLACC scale for pain
Time frame: during stitch removal (days 6 to 15)
Visual analog scale for operator's perception of the ease of stich removal
Time frame: 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
Time frame: 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.
Time frame: day 0