Skip to main content
OpenTrials
Completed

NCT Number: NCT02095366

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe Traumatic Pain Acute Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Numeric Pain Rating Scale > 5 / 10 Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emergency Department - Hospital Albertville, Albertville, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

Intravenous administration Patient receives simultaneously IV morphine administration and IN placebo spray.

Pain is controlled by:

  • at 0 minute : Placebo IN (2 sprays, one spray in each nostril) + morphine IV 0,1mg/kg
  • at 10 minutes and if NPRS>3 : Placebo IN (1 spray) + morphine IV 0,05mg/kg
  • at 20 minutes and if NPRS>3: Pacebo (1 spray) + morphine IV 0,05mg/kg

Sufentanil

Drug

Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV placebo administration and IN sufentanil spray.

Pain is controlled by:

  • at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV
  • at 10 minutes and if NPRS>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
  • at 20 minutes and if NPRS>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV

Placebo

Drug

Intravenous administration Patient receives simultaneously IV placebo administration and IN sufentanil spray.

Pain is controlled by:

  • at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV
  • at 10 minutes and if NPRS>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
  • at 20 minutes and if NPRS>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV

Other names: saline solution, NaCl 0.9%

Primary outcomes

  1. Efficiency of Analgesia

    Time frame: 30 minutes

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

Secondary outcomes

  1. Opioid-related side effects

    Time frame: 10 minutes

    Sedation Score, Breathing Rate, Oxygen Saturation, Arterial Blood Pressure, Heart rate, Nasal Ulceration.

    Proportion of patients having opioid-related side effects.

  2. Efficiency of Analgesia

    Time frame: 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.

  3. Patient Satisfaction

    Time frame: 40 min

  4. Specific Analysis for the pre hospital setting group: Efficiency of Analgesia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Fondation Apicil
  • SFMU

Registry information

Official study title

Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting. A Multicenter,Randomized,Controled, Comparative, Double Blinded Study

Acronym: ALGOFINE-2

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2014
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.