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| Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00416039 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fractures |
Drug: Midazolam Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Midazolam and morphine
|
Drug: Midazolam
0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine
|
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2: Placebo Comparator
placebo, Nacl 0.9 %, morphine 0.5 mg/kg
|
Drug: Placebo
placebo at 0.2 mg/kg and morphine 0.5 mg/kg
|
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| Ages Eligible for Study: | 5 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christelle Wille, MD | +33(0)1 44 49 42 90 | christelle.wille@nck.aphp.fr |
| Contact: Gerard Cheron, MD,PhD | +33(0)1 44 49 48 99 | gerard.cheron@nck.aphp.fr |
| France | |
| Hopital Necker enfants Malade - Department of Pediatric Emergency | Recruiting |
| Paris, France, 75015 | |
| Contact: Christelle Wille, MD 0144494290 christelle.wille@nck.aphp.fr | |
| Contact: Gerard Cheron, MD, PhD 0144494899 gerard.cheron@nck.aphp.fr | |
| Sub-Investigator: Christelle Wille, MD | |
| Principal Investigator: Gerard Cheron, MD, PhD | |
| Principal Investigator: | Gérard CHERON, MD, PhD | Assistance Publique - Hôpitaux de Paris |
More Information
| Responsible Party: | Department Clinical Research of Developpement ( Christophe Aucan ) |
| Study ID Numbers: | P051033 |
| Study First Received: | December 26, 2006 |
| Last Updated: | September 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00416039 History of Changes |
| Health Authority: | France: Ministry of Health |
|
midazolam sublingual oral morphine |
children bone fracture bone fracture with a deformed member |
|
Anesthetics, Intravenous Morphine Neurotransmitter Agents Tranquilizing Agents Fractures, Bone Wounds and Injuries Adjuvants, Immunologic Psychotropic Drugs Disorders of Environmental Origin Anesthetics |
Central Nervous System Depressants Narcotics Midazolam Anesthetics, General Hypnotics and Sedatives Emergencies Anti-Anxiety Agents Peripheral Nervous System Agents Analgesics Analgesics, Opioid |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Fractures, Bone Psychotropic Drugs Disorders of Environmental Origin Anesthetics Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Analgesics, Opioid Anesthetics, Intravenous |
Morphine Tranquilizing Agents Wounds and Injuries Central Nervous System Depressants Narcotics Midazolam Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |
