Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416039
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2006-12-26
Brief Title:
Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIDAZODOL
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 VASbefore and 30 minutes after the drugs administration and we will try to show a difference of 15 pointson 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 wont be enrolled as patients with femoral fracture which needs a local anaesthesia
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 VASbefore and 30 minutes after the drugs administration and we will try to show a difference of 15 pointson 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 wont be enrolled as patients with femoral fracture which needs a local anaesthesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None