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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00416039
First received: December 26, 2006
Last updated: August 27, 2013
Last verified: August 2013
  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 3

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:


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 ]

Enrollment: 60
Study Start Date: January 2007
Study Completion Date: February 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Hopital Necker enfants Malade - Department of Pediatric Emergency
Paris, France, 75015
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):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00416039     History of Changes
Other Study ID Numbers: P051033
Study First Received: December 26, 2006
Last Updated: August 27, 2013
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
Morphine
Midazolam
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014