Clinical trial NCT02420002: Pediatric Emergency Suture Care: a Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA
Official title: Suture Care in the Pediatric Emergency Department: a Randomized Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Wounds, Nonpenetrating
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* The patient was informed about the implementation of the study, its objectives, constraints and patient rights
* The legal representative of the patient must have given free and informed consent and signed the consent
* The patient must be affiliated with or beneficiary of a health insurance plan
* The patient is available for 15 days of follow-up
* The patient is consulting in the emergency department for a wound requiring the completion of a suture and for which the operator considers that the use of nitrous oxide is necessary and possible.

Exclusion Criteria:

* The patient is participating in another interventional study
* The patient has participated in another interventional study in the last 3 months
* The patient is in an exclusion period determined by a previous study
* The patient and/or his/her parents (or legal representative) refuses to sign the consent
* It proves impossible to correctly inform the patient and / or his/her parents (or legal representative)
* The patient has a contra-indication (or an incompatible drug combination) for a treatment required in this study (MEOPA): intracranial hypertension, impaired consciousness, pneumothorax, high rate oxygen-dependence, facial trauma preventing mask application.
* The patient has a condition that makes hypnosis impossible: e.g. encephalopathy, deafness, communication disorders, does not speak French
* Suture requiring surgical exploration or an operating room, or general anesthesia or an ears-nose-throat, orthopedic or visceral surgeon (e.g. wound of the oral cavity, abdominal or thoracic penetrating wound, finger or palm wound requiring exploration by an orthopaedist)
* Fractures associated with wound
* Use of level II/III analgesics before the beginning of pre-suture care support

Primary outcomes:
measure: Failure of pain control: yes/no
timeFrame: baseline (day 0)
measure: The FLACC score
timeFrame: day 0, during anesthetic injection
Secondary outcomes:
measure: Pain as measured via a VAS score for children over six years of age
timeFrame: day 0, during anesthetic injection
measure: The EVENDOL score
timeFrame: day 0, during anesthetic injection
measure: time lapsed between the beginning of the procedure and end of the suture
timeFrame: day 0
measure: time lapsed between the beginning of the procedure and the beginning of the suture
timeFrame: day 0
measure: MEOPA use
timeFrame: day 0
measure: Qualitative scale for general suturing conditions
timeFrame: day 0
measure: Use of physical restraint? yes/no
timeFrame: day 0
measure: Procedure failure: yes/non
timeFrame: day 0
measure: Visual analog scale for operator satisfaction in relation to the performed procedure
timeFrame: day 0
measure: Visual analog scale for operator's perception of the ease of the procedure
timeFrame: day 0
measure: Visual analog scale for parental satisfaction concerning pain care and comfort during suturing
timeFrame: day 0
measure: Visual analog scale for pain (only for children over 6)
timeFrame: during stitch removal (days 6 to 15)
measure: The EVENDOL scale for pain
timeFrame: during stitch removal (days 6 to 15)
measure: The FLACC scale for pain
timeFrame: during stitch removal (days 6 to 15)
measure: Visual analog scale for operator's perception of the ease of stich removal
timeFrame: during stitch removal (days 6 to 15)
measure: the child's behaviour during stitch removal
timeFrame: during stitch removal (days 6 to 15)
measure: The presence/absence of complications
timeFrame: day 0
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Philippe Fournier, MD
role: PRINCIPAL_INVESTIGATOR
References: