Intranasal Sufentanil Pain-management at Entrance of Emergency Department : Influence on Pain-relief Delay
NCT ID: NCT01954368
Last Updated: 2016-12-01
Study Results
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Basic Information
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COMPLETED
PHASE4
144 participants
INTERVENTIONAL
2014-01-31
2016-03-31
Brief Summary
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This randomized double-blind placebo-controlled study will focus on severe traumatic pain experienced by adults admitted in our ED.
We hypothesized that, in addition to traditional morphine titration, a single dose of IN sufentanil given at triage would significantly increase the proportion of patients relieved 30 minutes after their ED admission.
Time to discharge, proportion of side effects and satisfaction rates will also be recorded.
Detailed Description
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As intravenous (IV) opioid administration is world-wide recommended for severe pain treatment, delays from triage to room admission and to first IV injection directly influence this time to pain-relief. Moreover, it is proven that an incorrect adherence to morphine titration protocol can participate in ED oligoanalgesia.
Although ED experience in intranasal (IN) opioid administration is still lacking, this simple and non-invasive way of treating pain seems safe and promising. Opioid pharmacokinetic by IN route indeed is interesting for ED practitioners : while assuring a timely analgesia, the lower Cmax and delayed Tmax by IN route can theoretically limit the risk of respiratory depression, in comparison with IV route.
We propose a randomized double-blind placebo-controlled study on a convenience sample of adult patients admitted in our ED (annual census of 80000 attendances) for an isolated limb injury, and experiencing a severe pain (score \> 5/10 on numerical pain scale).
For primary outcome, we will compare the proportion of patients relieved (score \< 4/10) 30 minutes after admission, depending on the administration (or not) of a single intranasal dose of sufentanil (0,4 mcg/kg) given by the triage nurse.
Other secondary outcomes will include : evolution of pain scores in the first hour of admission and during entire ED stay, proportions of opioid-induced side-effects, proportions of patients receiving morphine and doses of morphine administrated, times for discharge, patient and staff satisfaction scores.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intranasal placebo
Patients receiving intranasal placebo at ED admission
Placebo
As soon as possible from ED admission, using a study drug volume schedule, triage nurse will administer to the patient a planned weight-based volume of intranasal placebo (normal saline solution).
Half of the dose will be administrated in each nostril. The patient will then rapidly be brought to emergency room and after his pain being reassessed, appropriate treatment (following current recommendations) will be given by the ED nurse.
Intranasal sufentanil
Patients receiving intranasal sufentanil at ED admission
Sufentanil
As soon as possible from ED admission, using a study drug volume schedule, triage nurse will administer to the patient a weight-based volume (corresponding to 0,4 mcg/kg) of intranasal sufentanil.
Half of the dose will be administrated in each nostril. The patient will then rapidly be brought to emergency room and after his pain being reassessed, appropriate treatment (following current recommendations) will be given by the ED nurse.
Interventions
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Placebo
As soon as possible from ED admission, using a study drug volume schedule, triage nurse will administer to the patient a planned weight-based volume of intranasal placebo (normal saline solution).
Half of the dose will be administrated in each nostril. The patient will then rapidly be brought to emergency room and after his pain being reassessed, appropriate treatment (following current recommendations) will be given by the ED nurse.
Sufentanil
As soon as possible from ED admission, using a study drug volume schedule, triage nurse will administer to the patient a weight-based volume (corresponding to 0,4 mcg/kg) of intranasal sufentanil.
Half of the dose will be administrated in each nostril. The patient will then rapidly be brought to emergency room and after his pain being reassessed, appropriate treatment (following current recommendations) will be given by the ED nurse.
Eligibility Criteria
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Inclusion Criteria
* Severe pain (score \> 5/10 on numerical pain scale)
* Age ≥ 18 years and \< 75 years
Exclusion Criteria
* Hemodynamic instability (systolic blood pressure \< 100 mmHg and/or blood pulse \> 110 / min)
* Oxygen saturation \< 96% on room air
* Chronic respiratory, renal or cardiac failure
* Impaired mental status (Glasgow Coma Scale \< 15)
18 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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Emergency Department
Nice, , France
Countries
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Other Identifiers
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2013-003308-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13-AOI-10
Identifier Type: -
Identifier Source: org_study_id