Single Traumatic Limb Injury With Severe Pain (Score > 5/10 on Numerical Pain Scale)Phase 4InSPEEDNCT01954368
Intranasal Sufentanil Pain-management at Entrance of Emergency Department : Influence on Pain-relief Delay
A Phase 4 study testing Sufentanil in people with Single Traumatic Limb Injury With Severe Pain (Score > 5/10 on Numerical Pain Scale), run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Non-invasive and simple, intranasal (IN) route of administration seems promising for pain management in the Emergency Department (ED), especially when used precociously by triage nurse to rapidly deliver the first opioid dose to severely painful patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Single Traumatic Limb Injury With Severe Pain (Score > 5/10 on Numerical Pain Scale)
- What is being tested?
- Sufentanil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Mar 2016
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single traumatic limb injury.
- Severe pain (score > 5/10 on numerical pain scale)
- Age ≥ 18 years and < 75 years
Who cannot join
- Abdominal, thoracic, vertebral or cranial injury associated
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Severe Traumatic Pain in the ED : Can we Improve Time to Pain-relief With a Single Dose of Intranasal Sufentanil Given at Triage ? A Randomized Double-blinded Placebo Controlled Study (InSPEED Study)
Non-invasive and simple, intranasal (IN) route of administration seems promising for pain management in the Emergency Department (ED), especially when used precociously by triage nurse to rapidly deliver the first opioid dose to severely painful patients.
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.
Read the detailed description
Time to pain-relief can vary widely in the Emergency Department (ED), depending on various factors such as ED overcrowding or inadequate training in pain management.
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.
- Being tested
- Placebo, Sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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.
SufentanilDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal placebo | Placebo comparator | Patients receiving intranasal placebo at ED admission Receives: Drug: Placebo |
| Intranasal sufentanil | Experimental | Patients receiving intranasal sufentanil at ED admission Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief assessment
Proportion of patients pain-relieved (score < 4/10 on numerical pain scale) at T30 (30 minutes after their admission)
Measured: 30 minutes after ED admission
Secondary outcomes (7)
opioids-related side-effects
Proportions of opioids-related side-effects.
Measured: 2h after last opioid injection.
Pain assessment
Proportions of patients having a score on numerical pain scale < 6/10 at room admission.
Measured: 30 minutes after ED admission
time to pain relief treatment
Delay from ED admission to first opioid injection (IV morphine or IN sufentanil).
Measured: 30 minutes after ED admission
Delay from first opioid injection to pain-relief
Delay from first opioid injection (IV morphine or IN sufentanil) to pain-relief.
Measured: 30 minutes
Patient satisfaction
Patient satisfaction score at discharge (an average time of 12h) (on a " zero-to-10 " scale)
Measured: at discharge
ED length of stay
ED length of stay.
Measured: 8 h after ED admission
Nurse satisfaction
Nurse satisfaction score at discharge (an average time of 12h)(on a " zero-to-10 " scale)
Measured: at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Traumatic Limb Injury With Severe Pain (Score > 5/10 on Numerical Pain Scale)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954368
- Sponsor's protocol ID
- 13-AOI-10
- Other IDs
- 2013-003308-38
- Acronym
- InSPEED
- Status last verified
- Nov 2016
- First submitted
- 20 Sep 2013
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Severe Traumatic Pain in the ED : Can we Improve Time to Pain-relief With a Single Dose of Intranasal Sufentanil Given at Triage ? A Randomized Double-blinded Placebo Controlled Study (InSPEED Study)
- ClinicalTrials.gov ID
- NCT01954368
- Acronym / sponsor ID
- InSPEED / 13-AOI-10
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Oct 2013 (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.
Non-invasive and simple, intranasal (IN) route of administration seems promising for pain management in the Emergency Department (ED), especially when used precociously by triage nurse to rapidly deliver the first opioid dose to severely painful patients.
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
Time to pain-relief can vary widely in the Emergency Department (ED), depending on various factors such as ED overcrowding or inadequate training in pain management.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal placebo | Placebo comparator | Drug: PlaceboPatients receiving intranasal placebo at ED admission |
| Intranasal sufentanil | Experimental | Drug: SufentanilPatients receiving intranasal sufentanil at ED admission |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single traumatic limb injury.
- Severe pain (score > 5/10 on numerical pain scale)
- Age ≥ 18 years and < 75 years
Key exclusion criteria (5 listed)
- Abdominal, thoracic, vertebral or cranial injury associated
- 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)
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 |
|---|---|---|
| PlaceboAs 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. | Drug | Intranasal placebo |
| SufentanilAs 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. | Drug | Intranasal sufentanil |
Primary outcome
Pain relief assessment
Time frame: 30 minutes after ED admission
Proportion of patients pain-relieved (score < 4/10 on numerical pain scale) at T30 (30 minutes after their admission)
7 secondary outcomes
opioids-related side-effects
Time frame: 2h after last opioid injection.
Pain assessment
Time frame: 30 minutes after ED admission
time to pain relief treatment
Time frame: 30 minutes after ED admission
Delay from first opioid injection to pain-relief
Time frame: 30 minutes
Patient satisfaction
Time frame: at discharge
ED length of stay
Time frame: 8 h after ED admission
Nurse satisfaction
Time frame: at discharge
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 1 Dec 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sufentanil in people with Single Traumatic Limb Injury With Severe Pain (Score > 5/10 on Numerical Pain Scale), run by Centre Hospitalier Universitaire de Nice 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 3 inclusion and 5 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 1 Dec 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pain relief assessment (time frame: 30 minutes after ED admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2016.