FracturesPhase 3MIDAZODOLNCT00416039
Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture
A Phase 3 study testing Midazolam in people with Fractures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Fractures
- What is being tested?
- Midazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Feb 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- ASA score > 2
- concomitant administration of oral analgesia (level II WHO classification) less than 6 hours
- concomitant administration of benzodiazepine less than 24 hours
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Necker enfants Malade - Department of Pediatric Emergency
Paris, 75015
About this study
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
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine
PlaceboDrug
placebo at 0.2 mg/kg and morphine 0.5 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Midazolam and morphine Receives: Drug: Midazolam |
| 2 | Placebo comparator | placebo, Nacl 0.9 %, morphine 0.5 mg/kg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the measurement of pain analogical scale values at 30 minutes between the two groups
Measured: after administration until 120 minutes
Secondary outcomes (7)
Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours.
Measured: after administration until 120 minutes
Pain Analogical scale Values after the treatment of the fracture
Measured: after administration until 120 minutes
Respiratory rate, Oxymetry
Measured: after administration until 120 minutes
Conscience (lethargy or irritability)
Measured: after administration until 120 minutes
nausea,
Measured: after administration until 120 minutes
skin hyperesthesia, rash
Measured: after administration until 120 minutes
children cooperation
Measured: after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionNov 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FracturesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Gérard CHERON, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416039
- Sponsor's protocol ID
- P051033
- Acronym
- MIDAZODOL
- Status last verified
- Nov 2025
- First submitted
- 26 Dec 2006
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
21480984
Wille-Ledon C, Chappuy H, Giraud C, Treluyer JM, Cheron 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. doi: 10.1111/j.1651-2227.2011.02311.x. Epub 2011 May 11.
PubMed 21480984
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00416039
- Acronym / sponsor ID
- MIDAZODOL / P051033
- Conditions
- Fractures
- Keywords
- midazolam, sublingual, oral morphine, children, bone fracture, bone fracture with a deformed member
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jan 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MidazolamMidazolam and morphine |
| 2 | Placebo comparator | Drug: Placeboplacebo, Nacl 0.9 %, morphine 0.5 mg/kg |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- ASA score > 2
- concomitant administration of oral analgesia (level II WHO classification) less than 6 hours
- concomitant administration of benzodiazepine less than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine | Drug | 1 |
| Placeboplacebo at 0.2 mg/kg and morphine 0.5 mg/kg | Drug | 2 |
Primary outcome
Difference in the measurement of pain analogical scale values at 30 minutes between the two groups
Time frame: after administration until 120 minutes
7 secondary outcomes
Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours.
Time frame: after administration until 120 minutes
Pain Analogical scale Values after the treatment of the fracture
Time frame: after administration until 120 minutes
Respiratory rate, Oxymetry
Time frame: after administration until 120 minutes
Conscience (lethargy or irritability)
Time frame: after administration until 120 minutes
nausea,
Time frame: after administration until 120 minutes
skin hyperesthesia, rash
Time frame: after administration until 120 minutes
children cooperation
Time frame: after surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background21480984
- Results publication: PubMed 21480984Wille-Ledon C, Chappuy H, Giraud C, Treluyer JM, Cheron 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. doi: 10.1111/j.1651-2227.2011.02311.x. Epub 2011 May 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gérard CHERON, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Midazolam in people with Fractures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the measurement of pain analogical scale values at 30 minutes between the two groups (time frame: after administration until 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00416039, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.