- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02420002
Pediatric Emergency Suture Care: a Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA (Hypno-Mo)
Suture Care in the Pediatric Emergency Department: a Randomized Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Philippe Fournier, MD
- Phone Number: +33.(0)4.66.68.30.50
- Email: philippe.fournier@chu-nimes.fr
Study Contact Backup
- Name: Carey M Suehs, PhD
- Phone Number: +33.(0)4.66.68.67.88
- Email: carey.suehs@chu-nimes.fr
Study Locations
-
-
-
Nîmes Cedex 09, France, 30029
- Recruiting
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
Principal Investigator:
- Philippe Fournier, MD
-
Sub-Investigator:
- Tu Anh Tran, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual care (MEOPA)
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 |
Patients randomized to this arm will receive usual care, including MEOPA inhalation during local anesthetic injection and suturing of a wound.
Other Names:
6 to 15 days after the initial suturing, stitches will be removed according to usual procedures.
|
Experimental: Experimental arm (Hypnosis)
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 |
6 to 15 days after the initial suturing, stitches will be removed according to usual procedures.
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Failure of pain control: yes/no
Time Frame: baseline (day 0)
|
Failure of pain control as defined by:
|
baseline (day 0)
|
The FLACC score
Time Frame: day 0, during anesthetic injection
|
day 0, during anesthetic injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain as measured via a VAS score for children over six years of age
Time Frame: day 0, during anesthetic injection
|
Score varying from 0.0 to 10.0
|
day 0, during anesthetic injection
|
The EVENDOL score
Time Frame: day 0, during anesthetic injection
|
day 0, during anesthetic injection
|
|
time lapsed between the beginning of the procedure and end of the suture
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 |
day 0
|
time lapsed between the beginning of the procedure and the beginning of the suture
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 |
day 0
|
MEOPA use
Time Frame: day 0
|
measured as litres/minute x minutes of administration
|
day 0
|
Qualitative scale for general suturing conditions
Time Frame: day 0
|
classified as verg good, good, correct, or bad
|
day 0
|
Use of physical restraint? yes/no
Time Frame: day 0
|
day 0
|
|
Procedure failure: yes/non
Time Frame: day 0
|
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
Time Frame: day 0
|
day 0
|
|
Visual analog scale for operator's perception of the ease of the procedure
Time Frame: day 0
|
day 0
|
|
Visual analog scale for parental satisfaction concerning pain care and comfort during suturing
Time Frame: day 0
|
Only one VAS per child
|
day 0
|
Visual analog scale for pain (only for children over 6)
Time Frame: during stitch removal (days 6 to 15)
|
during stitch removal (days 6 to 15)
|
|
The EVENDOL scale for pain
Time Frame: during stitch removal (days 6 to 15)
|
during stitch removal (days 6 to 15)
|
|
The FLACC scale for pain
Time Frame: during stitch removal (days 6 to 15)
|
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)
|
during stitch removal (days 6 to 15)
|
|
the child's behaviour during stitch removal
Time Frame: during stitch removal (days 6 to 15)
|
classified as: calm; afraid but capable of self-control; complementary means required
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during stitch removal (days 6 to 15)
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The presence/absence of complications
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.
|
day 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: Philippe Fournier, MD, Centre Hospitalier Universitaire de Nîmes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Wounds and Injuries
- Disease Attributes
- Emergencies
- Wounds, Nonpenetrating
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Anesthetics, Inhalation
- Nitrous Oxide
Other Study ID Numbers
- LOCAL/2013/PF-01
- 2014-002180-16 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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