Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting

Phase 4

Completed

• Conditions: Severe Traumatic Pain; Numeric Pain Rating Scale > 5 / 10
• Interventions: Drug: Sufentanil; Drug: Morphine; Drug: Placebo

• Registration Number: NCT02095366
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute traumatic pain in prehospital and Emergency departments (ED).

The investigators hypothesize that IN administration of Sufentanil is equal as compared with Intra veinous (IV) administration of Morphine wich is widely recommended in ED.

The investigators study is a multicentric, comparative, randomized, double-blind, double-placebo study, comparing quality of analgesia in both groups 30 minutes after first administration of opiates.

The investigators also asses side effects and patient satisfaction in both groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-24
• Primary Completion: 2016-04-10
• Study Completion: 2016-06-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

• Traumatic pain
• Numeric Pain Rating Scale (NPRS) >5 /10
• Age between 18 and 75 years old

Exclusion Criteria

• Medical pain (headache, chest pain,...)
• Respiratory, renal or hepatic insufficiency
• Drug addiction
• Medical or Chirurgical sinus history
• Oxygene saturation < 90%
• Systolic blood pressure < 90mmHg
• Head injury with a neurological Glasgow Coma Scale (GCS) < 14
• Opioid allergy
• Facial traumatism
• Patient unable do understand or assessing NPRS
• Opiates administration within 6 hours before admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IN Sufentanil AND IV Placebo	Sufentanil	Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration
IN Sufentanil AND IV Placebo	Placebo	Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration
IV Morphine AND IN Placebo	Placebo	Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray
IV Morphine AND IN Placebo	Morphine	Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray

Primary Outcome Measures

Name	Time	Method
Efficiency of Analgesia	30 minutes	Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration.

Secondary Outcome Measures

Name	Time	Method
Opioid-related side effects	10 minutes	Sedation Score, Breathing Rate, Oxygen Saturation, Arterial Blood Pressure, Heart rate, Nasal Ulceration.; Proportion of patients having opioid-related side effects.
Specific Analysis for the pre hospital setting group: Efficiency of Analgesia	Every 10 minutes	Patient self-assessed pain intensity, using Numeric Pain Rating Scale (0 to 10) at 10, 20 and 30 min after the first opiate administration
Efficiency of Analgesia	Every 10 minutes	Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 10 minutes and 20 minutes after the first opiate administration.
Patient Satisfaction	40 min

Trial Locations

Locations (6)

Emergency Department - Hospital Annecy; 🇫🇷 Annecy, France

Emergency Department - Hospital Albertville; 🇫🇷 Albertville, France

Emergency Department - University Hospital of Grenoble; 🇫🇷 Grenoble, France

Emergency Department - Hospital Voiron; 🇫🇷 Voiron, France

Emergency Department - Hospital Chambéry; 🇫🇷 Chambery, France

Emergency Department - Hospital Saint Jean de Maurienne; 🇫🇷 Saint-Jean-de-Maurienne, France