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Completed

NCT Number: NCT00416039

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

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.

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Key information

Conditions

Fractures Fractures, Bone Wounds and Injuries

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopital Necker enfants Malade - Department of Pediatric Emergency

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine

Placebo

Drug

placebo at 0.2 mg/kg and morphine 0.5 mg/kg

Primary outcomes

  1. Difference in the measurement of pain analogical scale values at 30 minutes between the two groups

    Time frame: after administration until 120 minutes

Secondary outcomes

  1. Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours.

    Time frame: after administration until 120 minutes

  2. Pain Analogical scale Values after the treatment of the fracture

    Time frame: after administration until 120 minutes

  3. Respiratory rate, Oxymetry

    Time frame: after administration until 120 minutes

  4. Conscience (lethargy or irritability)

    Time frame: after administration until 120 minutes

  5. nausea,

    Time frame: after administration until 120 minutes

  6. skin hyperesthesia, rash

    Time frame: after administration until 120 minutes

  7. children cooperation

    Time frame: after surgical procedure

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Clinical Randomized Study of Sublingual Midazolam in Association With Morphine by Oral Route in Arm Fracture in Children at the Emergency Children Care

Acronym: MIDAZODOL

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Dec 27, 2006
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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