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

Fractures Clinical Trial

— MIDAZODOL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416039
• Other study ID #: P051033
• Status: Completed
• Phase: Phase 3
• First received: December 26, 2006
• Last updated: August 27, 2013
• Start date: January 2007
• Est. completion date: February 2009

Study information

• Verified date: August 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

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

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

• Fractures
• Fractures, Bone

Intervention

Drug:
• Midazolam
0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine
• Placebo
placebo at 0.2 mg/kg and morphine 0.5 mg/kg

Locations

Country	Name	City	State
France	Hopital Necker enfants Malade - Department of Pediatric Emergency	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the measurement of pain analogical scale values at 30 minutes between the two groups		after administration until 120 minutes	Yes
Secondary	Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours.		after administration until 120 minutes	Yes
Secondary	Pain Analogical scale Values after the treatment of the fracture		after administration until 120 minutes	Yes
Secondary	Respiratory rate, Oxymetry		after administration until 120 minutes	Yes
Secondary	Conscience (lethargy or irritability)		after administration until 120 minutes	Yes
Secondary	nausea,		after administration until 120 minutes	Yes
Secondary	skin hyperesthesia, rash		after administration until 120 minutes	Yes
Secondary	children cooperation		after surgical procedure	No