Intranasal Sufentanil Pain-management at Entrance of Emergency Department : Influence on Pain-relief Delay (InSPEED)

• ClinicalTrials.gov Identifier: NCT01954368
• Recruitment Status: Completed
• Last Update Posted: December 1, 2016
• Sponsor: Centre Hospitalier Universitaire de Nice
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nice

Study Description

Brief 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.

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.

Condition or disease	Intervention/treatment	Phase
Single Traumatic Limb Injury With Severe Pain (Score > 5/10 on Numerical Pain Scale)	Drug: Placebo; Drug: Sufentanil	Phase 4

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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)
• Study Start Date: January 2014
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: March 2016

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Intranasal placebo; Patients receiving intranasal placebo at ED admission	Drug: 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.
Experimental: Intranasal sufentanil; Patients receiving intranasal sufentanil at ED admission	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. opioids-related side-effects [ Time Frame: 2h after last opioid injection. ]
   Proportions of opioids-related side-effects.
2. Pain assessment [ Time Frame: 30 minutes after ED admission ]
   Proportions of patients having a score on numerical pain scale < 6/10 at room admission.
3. time to pain relief treatment [ Time Frame: 30 minutes after ED admission ]
   Delay from ED admission to first opioid injection (IV morphine or IN sufentanil).
4. Delay from first opioid injection to pain-relief [ Time Frame: 30 minutes ]
   Delay from first opioid injection (IV morphine or IN sufentanil) to pain-relief.
5. Patient satisfaction [ Time Frame: at discharge ]
   Patient satisfaction score at discharge (an average time of 12h) (on a " zero-to-10 " scale)
6. ED length of stay [ Time Frame: 8 h after ED admission ]
   ED length of stay.
7. Nurse satisfaction [ Time Frame: at discharge ]
   Nurse satisfaction score at discharge (an average time of 12h)(on a " zero-to-10 " scale)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Single traumatic limb injury.
• Severe pain (score > 5/10 on numerical pain scale)
• Age ≥ 18 years and < 75 years

Exclusion Criteria:

• 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)

Contacts and Locations

Locations

France

Emergency Department

Nice, France, 06000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

More Information

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT01954368
• Other Study ID Numbers: 13-AOI-10; 2013-003308-38 ( EudraCT Number )
• First Posted: October 1, 2013
• Last Update Posted: December 1, 2016
• Last Verified: November 2016

Additional relevant MeSH terms:

Sufentanil; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics