Acute Pain Clinical Trial
— AEROMORPH1Official title:
First Evaluation of Morphine Hydrochloride by Nebulisation Compared to Intravenous Route in Healthy Volunteers: Preliminary Study Dose
Verified date | October 2019 |
Source | University Hospital, Rouen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Acute pain relief in emergency setting is still a public health priority. Pain is the primary
reason for emergency room use, but the situation of "oligo-analgesia" persists in all
countries. Intravenous morphine titration has become the standard method for severe acute
pain management in the emergency department, but it is still insufficiently implemented.
Deviations from the recommended protocol are common: initial additional loading doses,
unusually extended intervals between bolus, premature discontinuation. Several factors
contribute to these difficulties: heaviness of its setting up, especially in overcrowding
case, procedure rigidity, high consumption of nursing time. This method requires a systematic
intravenously route, which has several inconvenients: algogenic procedures, coupled initial
diagnostic venous sampling (delay for analgesia), excessive "medicalization" of ambulatory
patients (risk of infection and less mobility in the emergency department). An alternative to
reduce the analgesic latency in emergency department, without losing the benefits of
tolerance and safety should be welcome. The inhaled route looks promising, but has yet not
been enough evaluated in adults, and even less in the emergency room. Aerosol techniques
change from one study to another (molecules, materials, doses, painful intensities included,
judgment criteria and assessment times). A morphine titration by aerosol therapy could be an
interesting alternative to the standard method disadvantages, using faster, painless and
easier procedures, leading to "demedicalization".
To the need for stronger fundamentals, an additional study was designed in healthy
volunteers. The objective is to compare the titration of intravenous morphine titration
aerosol in moderate acute pain caused by electrostimulation.
To purchase this aim, we first need to determine accurately the smallest dose of effective
and well tolerated inhaled morphine, to provide the "bolus" dose we have to repeat by
titration, which is still currently unknown. This dose is called ED50, it's the effective
dose for at least 50% of healthy volunteers relieved. ED50 for intravenous morphine is also
needed to be established, unknown in this indication. The determination of these two parallel
ED50 would allow a reliable conversion factor between the two routes of administration for
morphine "bolus", which can then be tested in comparative titrations. To validate our induced
pain model in healthy volunteers, we also have chosen to fix in these conditions the ED50 of
fentanyl that the effective dose by nebulization is better known. This study would also
describe the pharmacokinetics of inhaled morphine and its derivatives after a single spray.
Status | Completed |
Enrollment | 35 |
Est. completion date | May 2, 2018 |
Est. primary completion date | May 2, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Sex: We choose to include 50% of men and 50% women (this covariate will be included in the parameters to balance the randomization list). - Age: Healthy volunteers will be between 18 to 60 years - Body mass index (BMI) between 19 and 29 kg / m² - effective contraception methods in women of childbearing age - Signature of informed consent - Affiliation to a social security scheme Exclusion Criteria: - Taking painkillers long-term - Taking psychotropic drugs long-term - Healthy volunteers with chronic pain - Drug addiction - Chronic neuropsychiatric pathology which may alter the pain threshold - Active Smoking - Chronic obstructive or restrictive respiratory pathology - Progressive known pathology (hypertension, kidney failure, heart, liver ...) - Chronic treatments are prohibited except oral contraception - Delirium or dementia, people who did not understand the pain scales - Lack of understanding of the French language - pregnancy and lactation - Poor venous capital - History of abnormal reaction at a local / regional anesthesia - Heart rate : HR <50 bpm - Hypotension TAsyst with systolic blood pressure <100 mm Hg - Atrioventricular block (PR interval> 200 ms) - Period exclusion of another biomedical research - Nobody placed under judicial protection, guardianship |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Rouen | Haute Normandie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
France,
Lvovschi V, Aubrun F, Bonnet P, Bouchara A, Bendahou M, Humbert B, Hausfater P, Riou B. Intravenous morphine titration to treat severe pain in the ED. Am J Emerg Med. 2008 Jul;26(6):676-82. doi: 10.1016/j.ajem.2007.10.025. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effective doses of intravenous morphine hydrochloride "bolus" and nebulized "bolus" in 50% of healthy painful volunteers | The primary endpoint is efficacy: relief from healthy volunteers thanks to VAS decreasing, defined as = 20 (100mm). At the end of the study the dose chosen is the effective dose for 50% of the volunteers. | 7 min | |
Secondary | safety | Check tolerance of aerosols on respiratory and systemically 2. Describe the pharmacokinetics of a "bolus" and a titration of morphine hydrochloride aerosol standardized, and of all its metabolites 3. Establish the concentration-effect relationship of a spray "bolus" and of a titration of morphine hydrochloride standardized (for the analgesic effect) using a pharmacokinetic / pharmacodynamic model (PK / PD) and mathematical modeling 4. Methodological validation by determining the ED50 of a inhaled fentanyl "bolus" 5. Establish pharmacokinetic bases that can provide a secure further study in the emergency room, targeting patients with severe spontaneous acute pain | 7 min |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04484610 -
Appropriate Opioid Quantities for Acute Pain - Pharmacist Study
|
Phase 4 | |
Recruiting |
NCT05054179 -
Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04548635 -
VR for Burn Dressing Changes at Home
|
Phase 2/Phase 3 | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Completed |
NCT06054945 -
Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
|
||
Completed |
NCT03825549 -
A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing
|
N/A | |
Completed |
NCT05995912 -
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
|
Phase 2 | |
Recruiting |
NCT05589246 -
Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure
|
N/A | |
Recruiting |
NCT05572190 -
Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects
|
Phase 1 | |
Terminated |
NCT04716413 -
Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
|
Phase 4 | |
Active, not recruiting |
NCT03537573 -
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
|
N/A | |
Not yet recruiting |
NCT06317844 -
Examination of Psychological and Physiological Pathways Linking Gratitude and Pain
|
N/A | |
Withdrawn |
NCT02957097 -
Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures
|
Phase 4 | |
Completed |
NCT02565342 -
Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery
|
Phase 4 | |
Terminated |
NCT02599870 -
Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures
|
N/A | |
Completed |
NCT02984098 -
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
|
Phase 4 | |
Completed |
NCT02380989 -
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain
|
Phase 2 | |
Completed |
NCT02489630 -
Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department
|
Phase 4 | |
Completed |
NCT03107338 -
Preventive Treatment of Pain After Dental Implant Surgery
|
Phase 4 | |
Completed |
NCT02817477 -
Intranasal Ketamine for Acute Traumatic Pain
|
Phase 4 |