Efficacy of Sublingual Midazolam in Association With Oral Morphine in

Status Completed

Clinical Trial 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 Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00416039
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase	Phase 3
Start date	January 2007
Completion date	February 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00137085` - Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation	N/A
Completed	`NCT00235404` - Randomized Controlled Trial of Health Care to Elderly Patients.	N/A
Completed	`NCT00152321` - Strategies Targeting Osteoporosis to Prevent Recurrent Fractures	N/A
Completed	`NCT01127711` - Cohort of Swedish Men	N/A
Completed	`NCT00060970` - Evaluating Muscle Function After Ankle Surgery	N/A
Completed	`NCT02576730` - Functional Outcome Assessment After (Calcaneal) Trauma Surgey	N/A
Completed	`NCT02074969` - Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures	N/A
Withdrawn	`NCT00355420` - Evaluation of the Change in Length of the Leg in Children After Treatment of Femur Fractures.	Phase 2
Completed	`NCT00767780` - The Effect of a New Biomechanical Device	N/A
Completed	`NCT00129142` - Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy	Phase 3
Terminated	`NCT03367169` - Surgery of the Pilon Fractures	N/A
Active, not recruiting	`NCT01452243` - Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial	Phase 3
Completed	`NCT00545350` - Exercise Intervention to Prevent Fall-related Fractures and Other Injuries : The Ossébo Study	N/A
Terminated	`NCT00387686` - A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures	Phase 2/Phase 3
Completed	`NCT02292316` - Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility	N/A
Completed	`NCT01136616` - CT Analysis of Structural Buttresses in the Traumatised Nose	Phase 2
Completed	`NCT02090972` - The Impact of Opioids in Fractures - a Case Control Study	N/A
Recruiting	`NCT02237040` - A New Treatment Protocol for Paediatric Mandibular Condylar Fractures	N/A
Completed	`NCT00872105` - Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle	N/A
Completed	`NCT00652548` - Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture — MIDAZODOL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms