NTNU intranasal naloxone trial (NINA-1) study protocol for a double-blind, double-dummy, non-inferiority randomised controlled trial comparing intranasal 1.4 mg to intramuscular 0.8 mg naloxone for prehospital use
| Autor: | Fridtjof Heyerdahl, Arne Kristian Skulberg, Morten Valberg, Ida Tylleskar, Anne-Cathrine Braarud, Sindre Mellesmo, Jostein Dale, Ola Dale |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Emergency Medical Services Blinding Adolescent medicine.medical_treatment Narcotic Antagonists statistics & research methods law.invention Randomized controlled trial Double-Blind Method Informed consent law Naloxone Clinical endpoint accident & emergency medicine Medicine Humans Administration Intranasal Aged Randomized Controlled Trials as Topic business.industry Norway Opioid overdose General Medicine medicine.disease Clinical trial Nasal spray medical ethics Emergency medicine Emergency Medicine clinical pharmacology Drug Overdose business medicine.drug toxicology |
| Zdroj: | BMJ Open, Vol 10, Iss 11 (2020) BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | Introduction Intranasal naloxone is widely used to treat opioid overdoses. The advantage of nasal administration compared to injection lies in its suitability for administration by lay people as it is needless. Approved formulations of nasal naloxone with bioavailability of approximately 50% have only undergone trials in healthy volunteers, while off-label nasal sprays with low bioavailability have been studied in patients. Randomised clinical trials are needed to investigate efficacy and safety of approved intranasal naloxone in patients suffering overdose. This study investigates whether the administration of 1.4 mg naloxone in 0.1 millilitres per dose is non- inferior to 0.8 mg intramuscular injection in patients treated for opioid overdose. Methods and analysis Sponsor is the Norwegian University of Science and Technology. The study has been developed in collaboration with user representatives. The primary endpoint is the restoration of spontaneous respiration ≥10 breaths/minute based on a sample of 200 opioid overdose cases. Double-dummy design ensures blinding, which will be maintained until the database is locked. Ethics and dissemination The study was approved by the Norwegian Medicines Agency and Regional Ethics Committees (REC: 2016/2000). It adheres to the Good Clinical Practice guidelines as set out by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Informed consent will be sought through a differentiated model. This allows for deferred consent after inclusion for patients who have regained the ability to consent. Patients who are unable to consent prior to discharge by emergency services are given written information and can withdraw at a later date in line with user recommendations. Metadata will be published in the NTNU Open repository. De-identified individual participant data will be made available to recipients conditional of data processor agreement being entered. Trial registrations: EudraCT number: 2016-004072-22 and Clinicaltrials.gov NCT03518021 © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
| Databáze: | OpenAIRE |
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