Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fractures
Intervention: Midazolam (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Gérard CHERON, MD, PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Overall contact:
Christelle Wille, MD, Phone: +33(0)1 44 49 42 90, Email: christelle.wille@nck.aphp.fr
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Difference in the measurement of pain analogical scale values at 30 minutes between the two groups
Secondary outcome: Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours.Pain Analogical scale Values after the treatment of the fracture Respiratory rate, Oxymetry Conscience (lethargy or irritability) nausea, skin hyperesthesia, rash children cooperation
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
Minimum age: 5 Years.
Maximum age: 16 Years.
Gender(s): Both.
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
Locations and Contacts
Christelle Wille, MD, Phone: +33(0)1 44 49 42 90, Email: christelle.wille@nck.aphp.fr
Hopital Necker enfants Malade - Department of Pediatric Emergency, Paris 75015, France; Recruiting
Christelle Wille, MD, Phone: 0144494290, Email: christelle.wille@nck.aphp.fr
Gerard Cheron, MD, PhD, Phone: 0144494899, Email: gerard.cheron@nck.aphp.fr
Christelle Wille, MD, Sub-Investigator
Gerard Cheron, MD, PhD, Principal Investigator
Additional Information
Starting date: January 2007
Ending date: February 2009
Last updated: September 5, 2008
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