Pain Clinical Trial
— PAIN-KOfficial title:
Prehospital Analgesia With Intra-Nasal Ketamine
Verified date | October 2018 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Acute painful conditions make-up a large proportion of pre-hospital transports in British
Columbia (BC) yet Basic Life Support (BLS) paramedics have limited options to provide
analgesia and therefore adequate and timely pain relief is often significantly delayed.
Inhaled nitrous oxide is commonly used as a pre-hospital analgesic and is considered "usual
care" for pre-hospital providers in BC, but its utility in severe pain is uncertain.
Moreover, nitrous oxide is limited in its effectiveness by a short duration of action,
nausea, vomiting, and the necessity for patient cooperation.
IN Ketamine has been shown to provide rapid, easily-administered, and well-tolerated
analgesia in many settings. The investigators believe that the addition of IN ketamine to
usual care with nitrous oxide inhalation for adults experiencing moderate to severe intensity
acute pain in the pre-hospital setting will result in improved pain severity, improved
patient-reported comfort, and improved patient satisfaction.
Status | Completed |
Enrollment | 120 |
Est. completion date | May 24, 2018 |
Est. primary completion date | May 24, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who have an acute painful condition, as determined by the Emergency Health Services attendant - A pain score of 5 or greater (signifying moderate or severe pain) - Desire for analgesia when queried. Exclusion Criteria: - Less than 18 years of age. - Previous hypersensitivity, intolerance or allergy to ketamine - Chest pain - Altered mental status - Inability self-report pain score - Pregnancy - Nasal occlusion - Systolic Blood Pressure < 90 mm Hg - Requiring immediate attention of the paramedic - Ineligible to receive inhaled nitrous oxide as per BC EHS protocols |
Country | Name | City | State |
---|---|---|---|
Canada | British Columbia Emergency Health Services Station 249 | Surrey | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | British Columbia Emergency Health Services |
Canada,
Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229. — View Citation
Bahreini M, Jalili M, Moradi-Lakeh M. A comparison of three self-report pain scales in adults with acute pain. J Emerg Med. 2015 Jan;48(1):10-8. doi: 10.1016/j.jemermed.2014.07.039. Epub 2014 Sep 27. — View Citation
Borland M, Jacobs I, King B, O'Brien D. A randomized controlled trial comparing intranasal fentanyl to intravenous morphine for managing acute pain in children in the emergency department. Ann Emerg Med. 2007 Mar;49(3):335-40. Epub 2006 Oct 25. — View Citation
Borland ML, Clark LJ, Esson A. Comparative review of the clinical use of intranasal fentanyl versus morphine in a paediatric emergency department. Emerg Med Australas. 2008 Dec;20(6):515-20. doi: 10.1111/j.1742-6723.2008.01138.x. Erratum in: Emerg Med Australas. 2009 Apr;21(2):166. Dosage error in article text. Emerg Med Australas. 2009 Jun;21(3):246. Dosage error in article text. — View Citation
Borland ML, Jacobs I, Geelhoed G. Intranasal fentanyl reduces acute pain in children in the emergency department: a safety and efficacy study. Emerg Med (Fremantle). 2002 Sep;14(3):275-80. — View Citation
Carr DB, Goudas LC, Denman WT, Brookoff D, Staats PS, Brennen L, Green G, Albin R, Hamilton D, Rogers MC, Firestone L, Lavin PT, Mermelstein F. Safety and efficacy of intranasal ketamine for the treatment of breakthrough pain in patients with chronic pain: a randomized, double-blind, placebo-controlled, crossover study. Pain. 2004 Mar;108(1-2):17-27. — View Citation
Chambers JA, Guly HR. The need for better pre-hospital analgesia. Arch Emerg Med. 1993 Sep;10(3):187-92. — View Citation
Ducassé JL, Siksik G, Durand-Béchu M, Couarraze S, Vallé B, Lecoules N, Marco P, Lacombe T, Bounes V. Nitrous oxide for early analgesia in the emergency setting: a randomized, double-blind multicenter prehospital trial. Acad Emerg Med. 2013 Feb;20(2):178-84. doi: 10.1111/acem.12072. — View Citation
Faddy SC, Garlick SR. A systematic review of the safety of analgesia with 50% nitrous oxide: can lay responders use analgesic gases in the prehospital setting? Emerg Med J. 2005 Dec;22(12):901-8. Review. — View Citation
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-404. doi: 10.1016/j.pain.2011.07.005. — View Citation
Galinski M, Dolveck F, Combes X, Limoges V, Smaïl N, Pommier V, Templier F, Catineau J, Lapostolle F, Adnet F. Management of severe acute pain in emergency settings: ketamine reduces morphine consumption. Am J Emerg Med. 2007 May;25(4):385-90. — View Citation
Graudins A, Meek R, Egerton-Warburton D, Oakley E, Seith R. The PICHFORK (Pain in Children Fentanyl or Ketamine) trial: a randomized controlled trial comparing intranasal ketamine and fentanyl for the relief of moderate to severe pain in children with limb injuries. Ann Emerg Med. 2015 Mar;65(3):248-254.e1. doi: 10.1016/j.annemergmed.2014.09.024. Epub 2014 Nov 18. — View Citation
Green SM, Andolfatto G, Krauss BS. Ketamine and intracranial pressure: no contraindication except hydrocephalus. Ann Emerg Med. 2015 Jan;65(1):52-4. doi: 10.1016/j.annemergmed.2014.08.025. Epub 2014 Sep 20. — View Citation
Holdgate A, Cao A, Lo KM. The implementation of intranasal fentanyl for children in a mixed adult and pediatric emergency department reduces time to analgesic administration. Acad Emerg Med. 2010 Feb;17(2):214-7. doi: 10.1111/j.1553-2712.2009.00636.x. — View Citation
Huge V, Lauchart M, Magerl W, Schelling G, Beyer A, Thieme D, Azad SC. Effects of low-dose intranasal (S)-ketamine in patients with neuropathic pain. Eur J Pain. 2010 Apr;14(4):387-94. doi: 10.1016/j.ejpain.2009.08.002. Epub 2009 Sep 3. — View Citation
Jennings PA, Cameron P, Bernard S. Epidemiology of prehospital pain: an opportunity for improvement. Emerg Med J. 2011 Jun;28(6):530-1. doi: 10.1136/emj.2010.098954. Epub 2010 Aug 2. — View Citation
Jennings PA, Cameron P, Bernard S. Ketamine as an analgesic in the pre-hospital setting: a systematic review. Acta Anaesthesiol Scand. 2011 Jul;55(6):638-43. doi: 10.1111/j.1399-6576.2011.02446.x. Epub 2011 May 16. Review. — View Citation
Jensen MP, Martin SA, Cheung R. The meaning of pain relief in a clinical trial. J Pain. 2005 Jun;6(6):400-6. — View Citation
Johansson J, Sjöberg J, Nordgren M, Sandström E, Sjöberg F, Zetterström H. Prehospital analgesia using nasal administration of S-ketamine--a case series. Scand J Trauma Resusc Emerg Med. 2013 May 14;21:38. doi: 10.1186/1757-7241-21-38. — View Citation
Karlsen AP, Pedersen DM, Trautner S, Dahl JB, Hansen MS. Safety of intranasal fentanyl in the out-of-hospital setting: a prospective observational study. Ann Emerg Med. 2014 Jun;63(6):699-703. doi: 10.1016/j.annemergmed.2013.10.025. Epub 2013 Nov 22. — View Citation
Kulbe J. The use of ketamine nasal spray for short-term analgesia. Home Healthc Nurse. 1998 Jun;16(6):367-70. — View Citation
Lord B, Cui J, Kelly AM. The impact of patient sex on paramedic pain management in the prehospital setting. Am J Emerg Med. 2009 Jun;27(5):525-9. doi: 10.1016/j.ajem.2008.04.003. — View Citation
Malinovsky JM, Servin F, Cozian A, Lepage JY, Pinaud M. Ketamine and norketamine plasma concentrations after i.v., nasal and rectal administration in children. Br J Anaesth. 1996 Aug;77(2):203-7. — View Citation
Marinangeli F, Narducci C, Ursini ML, Paladini A, Pasqualucci A, Gatti A, Varrassi G. Acute pain and availability of analgesia in the prehospital emergency setting in Italy: a problem to be solved. Pain Pract. 2009 Jul-Aug;9(4):282-8. doi: 10.1111/j.1533-2500.2009.00277.x. Epub 2009 Mar 16. — View Citation
Marland S, Ellerton J, Andolfatto G, Strapazzon G, Thomassen O, Brandner B, Weatherall A, Paal P. Ketamine: use in anesthesia. CNS Neurosci Ther. 2013 Jun;19(6):381-9. doi: 10.1111/cns.12072. Epub 2013 Mar 22. Review. — View Citation
McLean SA, Maio RF, Domeier RM. The epidemiology of pain in the prehospital setting. Prehosp Emerg Care. 2002 Oct-Dec;6(4):402-5. — View Citation
Murphy A, McCoy S, O'Reilly K, Fogarty E, Dietz J, Crispino G, Wakai A, O'Sullivan R. A Prevalence and Management Study of Acute Pain in Children Attending Emergency Departments by Ambulance. Prehosp Emerg Care. 2016;20(1):52-8. doi: 10.3109/10903127.2015.1037478. Epub 2015 May 29. — View Citation
Oglesbee S, Selde W. Nitrous oxide. New delivery of an old drug. JEMS. 2014 Apr;39(4):34-7. — View Citation
Plunkett A, Turabi A, Wilkinson I. Battlefield analgesia: a brief review of current trends and concepts in the treatment of pain in US military casualties from the conflicts in Iraq and Afghanistan. Pain Manag. 2012 May;2(3):231-8. doi: 10.2217/pmt.12.18. — View Citation
Reid C, Hatton R, Middleton P. Case report: prehospital use of intranasal ketamine for paediatric burn injury. Emerg Med J. 2011 Apr;28(4):328-9. doi: 10.1136/emj.2010.092825. Epub 2011 Feb 3. — View Citation
Weber F, Wulf H, Gruber M, Biallas R. S-ketamine and s-norketamine plasma concentrations after nasal and i.v. administration in anesthetized children. Paediatr Anaesth. 2004 Dec;14(12):983-8. — View Citation
Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18. Review. — View Citation
Yanagihara Y, Ohtani M, Kariya S, Uchino K, Hiraishi T, Ashizawa N, Aoyama T, Yamamura Y, Yamada Y, Iga T. Plasma concentration profiles of ketamine and norketamine after administration of various ketamine preparations to healthy Japanese volunteers. Biopharm Drug Dispos. 2003 Jan;24(1):37-43. — View Citation
Yeaman F, Meek R, Egerton-Warburton D, Rosengarten P, Graudins A. Sub-dissociative-dose intranasal ketamine for moderate to severe pain in adult emergency department patients. Emerg Med Australas. 2014 Jun;26(3):237-42. doi: 10.1111/1742-6723.12173. Epub 2014 Apr 8. — View Citation
* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion experiencing 2-point or more pain score reduction at 30 minutes | The proportion of patients experiencing a 2-point or more reduction in NRS pain score at 30 minutes. | 30 minutes. | |
Secondary | Proportion experiencing 2-point or more pain score reduction at 15 minutes | The proportion of patients experiencing a 2-point or more reduction in NRS pain score at 15 minutes. | 15 minutes | |
Secondary | The proportion of patients feeling "a lot better" or "moderately better" at 30 minutes post medication delivery or hospital at hospital arrival | The proportion of patients feeling "a lot better" or "moderately better" at 30 minutes post medication delivery or hospital at hospital arrival | 30 minutes | |
Secondary | The proportion of patients feeling "a lot better" or "moderately better" at 15 minutes. | The proportion of patients feeling "a lot better" or "moderately better" at 15 minutes. | 15 minutes | |
Secondary | The proportion of patients feeling "a lot better", "moderately better" or "a little better" at 15 minutes and at 30 minutes. | The proportion of patients feeling "a lot better", "moderately better" or "a little better" at 15 minutes and at 30 minutes. | 15 minutes, 30 minutes | |
Secondary | Adverse Events | Incidence of adverse events. | Every 15 minutes until care transferred to Emergency Department | |
Secondary | Patient Satisfaction | Patient satisfaction with analgesia provided using a ten point numeric rating scale anchored with 0 = "not at all satisfied" and 10 = "completely satisfied" on hospital arrival. | At 30 minutes post analgesia administration. | |
Secondary | Provider Satisfaction | Paramedic satisfaction with analgesia provided using a ten point numeric rating scale anchored with 0 = "not at all satisfied" and 10 = "completely satisfied" on hospital arrival. | At 30 minutes post analgesia administration. | |
Secondary | Median Nitrous Oxide Consumption | Median nitrous oxide consumption in each group will be recorded and compared. | At 30 minutes post analgesia administration. | |
Secondary | Median reduction in pain score at 15 minutes | Median reduction in NRS pain score at 15 minutes | 15 minutes | |
Secondary | Median reduction in pain score at 30 minutes | Median reduction in NRS pain score at 30 minutes | 30 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|