Multimodal Oral Analgesia for Trauma in the Emergency Department

Pain Clinical Trial

— START  

Official title:

Multimodal Oral Analgesia for Trauma in the Emergency Department: a Prospective Observational Study of a Nurse-directed Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380247
• Other study ID #: 38RC17.157
• Secondary ID: RCB-2017-A01706-
• Status: Completed
• Start date: October 12, 2017
• Est. completion date: July 6, 2018

Study information

• Verified date: August 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The prevalence of pain in the emergency department is estimated between 60% and 78%. However, many studies reported oligo analgesia in about half of patient admitted to the emergency department. The delay before effective analgesia is one of the main causes of oligoanalgesia. The use of nurse-directed protocol allows the administration of analgesic upon admission to the emergency department. Nevertheless the need of intravenous access may delay analgesia. The use of oral form analgesics even with immediate release does not allow effective analgesia before 20 min. Pain management protocol in the emergency reception desk of CHU Grenoble Alpes (CHUGA) includes paracetamol that can be combined with oxycodone tablets depending on the pain intensity. For any mono traumatized it is possible to associate self-administer methoxyflurane inhaler. The pain management protocol is already used in the emergency reception desk of CHU Grenoble Alpes.The different analgesics( paracetamol,oral oxycodone, methoxyflurane) are already administered as part of routine care.The use of these different analgesics means would allow a rapid and adapted effectiveness to the pain intensity. However, there are no data on the efficacy and acceptability of such an early multimodal analgesia protocol in the emergency department.

Description:

200 Patients will be included from 8:00 am to 8:00 pm and will receive a multimodal analgesia under the nurse-directed pain management protocol (paracetamol +/- oral oxycodone +/- methoxyflurane) as part of routine medical care.

The pain will be evaluated (Numerical rating scale) prior to the administration and reassessed by a nurse every 5 minutes for 30 minutes and then at 45min and 1 hour after administration of the pain protocol. Satisfaction of patients and caregivers will also be assessed at the end of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 6, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients : = 18 year and older

• Trauma pain

• NRS= 4

• Non- opposition to participate in the study

Exclusion Criteria:

• Trauma with at least one of the following severity criteria:

• Suspected (from mechanism) or confirmed multiple trauma

• State of shock

• Suspected or proven trauma to the thorax (excluding isolated rib fractures with Spo2 = 98%)

• Suspected or proven Abdominal trauma

• Suspected or proven pelvic trauma

• Severe traumatic brain injury

• Altered level of consciousness (Glasgow score < 15)

• Patients who took any analgesic within 4 hours prior to admission (except paracetamol)

• Use of nitrous oxide in the hour before admission

• Patient requiring an intravenous access at admission (e.g. : open fracture displaced)

• Hypersensitivity to one of the molecules of the analgesia protocol

• Known pregnant or likely to be pregnant women at the time of inclusion

• Subject in an exclusion period from another study

• Subjects under tutelage or subjects deprived of liberty

• Patients to be unable to understand the purpose of study

Related Conditions & MeSH terms

• Emergencies
• Pain

Locations

Country	Name	City	State
France	Emergency Department of University Hospital Grenoble	Grenoble	Auvergne Rhonalpes

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Mundipharma Pte Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a score of less than or equal to 3 on a pain Numeric Rating scale (NRS) (0-10) 15 minutes after inclusion	NRS scale (0-10)	15 minutes after inclusion
Secondary	Secondary efficacy criteria	Delay of pain relief defined by a 2 point reduction in the NRS scale (0-10)	15, 30 and 45 min (after inclusion)
Secondary	Number of patient with 30% reduction in pain intensity	NRS scale (0-10)	15,30 and 45 min (after inclusion)
Secondary	Satisfaction of caregiver and patient	Patient and caregiver satisfaction evaluated by a visual analog scale (VAS), covering the whole range of analgesic management and in particular each component of multimodal analgesia. The VAS scale ranges are : (not at all satisfied I will not take again - quite satisfied i will take again) for the patient and (not at all satisfied i will not give again - quite satisfied i will give again) for the caregiver	1h after inclusion