Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Fractures

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Difference in the measurement of pain analogical scale values at 30 minutes between the two groups [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours. [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
Pain Analogical scale Values after the treatment of the fracture [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
Respiratory rate, Oxymetry [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
Conscience (lethargy or irritability) [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
nausea, [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
skin hyperesthesia, rash [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
children cooperation [ Time Frame: after surgical procedure ] [ Designated as safety issue: No ]

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
Experimental: 1 Midazolam and morphine	Drug: Midazolam 0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine
Placebo Comparator: 2 placebo, Nacl 0.9 %, morphine 0.5 mg/kg	Drug: Placebo placebo at 0.2 mg/kg and morphine 0.5 mg/kg

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

Ages Eligible for Study:	5 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416039

Contacts

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

Locations

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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Gérard CHERON, MD, PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wille-Ledon C, Chappuy H, Giraud C, Tréluyer JM, Chéron G. Comparison of a morphine and midazolam combination with morphine alone for paediatric displaced fractures: a randomized study. Acta Paediatr. 2011 Nov;100(11):e203-7. Epub 2011 May 11.

Responsible Party:	Christophe Aucan, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier:	NCT00416039 History of Changes
Other Study ID Numbers:	P051033
Study First Received:	December 26, 2006
Last Updated:	September 5, 2008
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

midazolam
sublingual
oral morphine

children
bone fracture
bone fracture with a deformed member

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Midazolam
Morphine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs

Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012