Clinical trial NCT00416039: Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture
Official title: Clinical Randomized Study of Sublingual Midazolam in Association With Morphine by Oral Route in Arm Fracture in Children at the Emergency Children Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fractures
Keywords: midazolam
sublingual
oral morphine
children
bone fracture
bone fracture with a deformed member
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a randomized simple-blind monocentric study; the group A will receive oral morphine with placebo and the group B will receive oral morphine with sublingual midazolam. The aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo.

Detailed description: Fracture is often responsible of pain in the paediatric emergency department (ED). This pain is very severe and needs effective drugs.

During a study made at the ED of Necker Enfants Malades Hospital, it has been shown that the oral morphine had a limited action on this kind of pain. Therefore it is interesting to increase the analgesia by making a drug association, for example with the midazolam witch is a benzodiazepine with a sedative and anxiolytic action, and which has got the MMA for the intravenous and the intra rectal forms for children older than 6 months.

The intravenous form has some disadvantages like an extra work and an increase of risk of side effects.

That is why the sublingual form seems to be interesting in this context. Even if some studies have shown the benefit of midazolam as a preanesthetic medication given to children scheduled for a surgical procedure, none has shown the interest of sublingual midazolam associated with oral morphine to relieve the pain due to a displaced fracture.

The aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo.

It is a randomized simple-blind monocentric study; the group A will receive oral morphine with placebo and the group B will receive oral morphine with sublingual midazolam . The pain will be quantified thanks to the visual analogical scale (VAS)before and 30 minutes after the drugs administration, and we will try to show a difference of 15 points(on 100) of the VAS at 30 minutes between the two groups.

60 patients aged from 5 to 16 years old and having a displaced fracture will be enrolled in this study which will last 1 year.

Patients having a contra-indication for morphine and midazolam won't be enrolled as patients with femoral fracture which needs a local anaesthesia.

Eligibility criteria: Inclusion Criteria:

* children between 5 and 16 years old
* children with a disjoined bone fracture
* children needed oral morphine analgesia
* written informed consent from one or the two parents or legal pad

Exclusion Criteria:

* ASA score \> 2
* concomitant administration of oral analgesia (level II WHO classification) less than 6 hours
* concomitant administration of benzodiazepine less than 24 hours

Primary outcomes:
measure: Difference in the measurement of pain analogical scale values at 30 minutes between the two groups
timeFrame: after administration until 120 minutes
Secondary outcomes:
measure: Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours.
timeFrame: after administration until 120 minutes
measure: Pain Analogical scale Values after the treatment of the fracture
timeFrame: after administration until 120 minutes
measure: Respiratory rate, Oxymetry
timeFrame: after administration until 120 minutes
measure: Conscience (lethargy or irritability)
timeFrame: after administration until 120 minutes
measure: nausea,
timeFrame: after administration until 120 minutes
measure: skin hyperesthesia, rash
timeFrame: after administration until 120 minutes
measure: children cooperation
timeFrame: after surgical procedure
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker enfants Malade - Department of Pediatric Emergency
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Gérard CHERON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wille-Ledon C, Chappuy H, Giraud C, Treluyer JM, Cheron G. Comparison of a morphine and midazolam combination with morphine alone for paediatric displaced fractures: a randomized study. Acta Paediatr. 2011 Nov;100(11):e203-7. doi: 10.1111/j.1651-2227.2011.02311.x. Epub 2011 May 11.