CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
NCT Number: NCT02420002
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.
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Notify Me4 year–17 year
All sexes
Interventional
Phase 4
Nîmes, 30029, France
The secondary objectives of this study are to compare the two study arms in terms of:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients randomized to this arm will receive usual care, including MEOPA inhalation during local anesthetic injection and suturing of a wound.
Other names: equimolar mixture of nitrous oxide and oxygen
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.
Time frame: baseline (day 0)
Failure of pain control as defined by:
Time frame: day 0, during anesthetic injection
Time frame: day 0, during anesthetic injection
Score varying from 0.0 to 10.0
Time frame: day 0, during anesthetic injection
Time frame: day 0
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
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
measured as litres/minute x minutes of administration
Time frame: day 0
classified as verg good, good, correct, or bad
Time frame: day 0
Time frame: day 0
i..e, was it necessary to resort to complementary means in order to perform the suture?
Time frame: day 0
Time frame: day 0
Time frame: day 0
Only one VAS per child
Time frame: during stitch removal (days 6 to 15)
Time frame: during stitch removal (days 6 to 15)
Time frame: during stitch removal (days 6 to 15)
Time frame: during stitch removal (days 6 to 15)
Time frame: during stitch removal (days 6 to 15)
classified as: calm; afraid but capable of self-control; complementary means required
Time frame: day 0
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.
Centre Hospitalier Universitaire de Nīmes
Other
Suture Care in the Pediatric Emergency Department: a Randomized Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA
Acronym: Hypno-Mo
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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