PainPhase 4PAIN-KNCT02753114
Prehospital Analgesia With Intra-Nasal Ketamine
A Phase 4 study testing Ketamine and Normal Saline in people with Pain and Acute Pain, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute Pain
- What is being tested?
- Ketamine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 6 Nov 2017to 24 May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Less than 18 years of age.
- Previous hypersensitivity, intolerance or allergy to ketamine
- Chest pain
- Altered mental status
- Inability self-report pain score
- Pregnancy
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Emergency Health Services Station 249
Surrey, British Columbia, V3V 1Z2
About this study
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.
Read the detailed description
Purpose:
The purpose of this study is to see whether intra-nasal (IN) Ketamine (50 mg / ml) solution (Sandoz; Drug Identification Number (DIN) 02246796) administered via mucosal atomization device (LMA MAD300 Nasal TM; Wolfe Tory Medical Inc., San Diego, CA), in addition to usual care with nitrous oxide inhalation, to pre-hospital patients being transported by British Columbia Emergency Health Services (BC EHS) Basic Life Support (BLS) paramedics with moderate to severe pain (pain > 5/10 on a validated numerical rating scale or NRS) will improve pain relative to usual care plus placebo.
Hypothesis:
It is hypothesized 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 a greater proportion of patients experiencing a 2-point or more reduction in verbal numerical rating scale (VNRS) pain score within 30 minutes, as well as improved patient-reported comfort, reduced nitrous oxide requirements, and improved patient and provider satisfaction compared to usual care alone.
Background:
Acute painful conditions make-up a large proportion of pre-hospital transports yet 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 BLS pre-hospital providers. Nitrous oxide has been shown to be effective for analgesia in patients with moderate pain but its utility in severe pain is uncertain. No alternative treatments exist for BLS providers in the pre-hospital setting. Intra-nasal ketamine is a safe, well-tolerated means of providing analgesia and has been proven to work in the pre-hospital setting without the need for cardio-respiratory monitoring.
Objectives:
The objective of this study is to collect pilot data to compare the addition of intranasal Ketamine or an intranasal placebo in terms of efficacy and effectiveness in patients receiving usual care with nitrous oxide for moderate to severe pain.
Secondary objectives will be to assess subjective improvement in pain, effect on nitrous oxide requirements, incidence of adverse effects, patient and provider satisfaction, and study recruitment potential. These data will inform future large-scale trial designs and will be used to validate a proposed 7-point patient-reported pain improvement scale.
Research Methods:
This will be a randomized double-blind pilot trial conducted in the pre-hospital setting in the lower mainland. The pilot series will constitute 40 patients (20 per group). The sample size for a larger randomized controlled trial will then be calculated using the effect size and variance of the accrued data.
Statistical Analysis:
A statistician will be contracted to independently oversee the analysis of study results. The intention-to-treat principal will be used to analyze all data. Data will be analyzed using descriptive statistics. Categorical data will be presented as frequency and percentage frequency of occurrence. Continuous data will be presented as medians with ranges and interquartile ranges (IQRs). Adverse effects will be described as frequency of occurrence with 95% confidence intervals. A p-value of 0.05 will be considered statistically significant.
- Conditions
- Pain, Acute Pain
- Being tested
- Ketamine, Normal Saline
- Keywords
- Ketamine, Intranasal, Emergency Medical Services, Pain, Analgesia
- Medical subject headings
- Pain, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Sandoz DIN 02246796, Ketalar
Intranasal Ketamine administered via mucosal atomization device at 0.5 - 1 mg / kg IN.
Normal SalineDrug
Also called Saline placebo
Intranasal Normal Saline administered via mucosal atomization device.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Ketamine | Experimental | Ketamine dosing will be weight-based as follows: 30mg of IN ketamine for patients weighing 50 kg or less; 50 mg of IN ketamine for patients weighing 50 kg to 100 kg; and 75 mg of IN ketamine for patients weighing greater than 100 kg (i.e. 0.5 mg/kg to 1.0 mg/kg of intranasal ketamine). Syringes containing ketamine will be prepared from the intravenous formulation of Ketamine (50 mg / ml) solution (Sandoz; DIN 02246796) and stored in pre-filled 5 ml syringes. Ketamine will be administered to patients through a mucosal atomization device. One-half of the pre-specified volume will be administered into each nare. No repeat doses will be administered. Receives: Drug: Ketamine |
| Placebo | Placebo comparator | Syringes containing normal saline will be prepared such that the volume of normal saline in 5 ml syringes matches that of the ketamine for each of the weight based groups previously specified in the Treatment Arm Description. Syringes containing normal saline will also be labeled "Study Drug". The normal saline will also be administered to patients through a mucosal atomization device. One-half of the pre-specified volume will be administered into each nare. No repeat doses of placebo will be administered. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes.
Secondary outcomes (10)
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.
Measured: 15 minutes
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
Measured: 30 minutes
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.
Measured: 15 minutes
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.
Measured: 15 minutes, 30 minutes
Adverse Events
Incidence of adverse events.
Measured: Every 15 minutes until care transferred to Emergency Department
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.
Measured: At 30 minutes post analgesia administration.
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.
Measured: At 30 minutes post analgesia administration.
Median Nitrous Oxide Consumption
Median nitrous oxide consumption in each group will be recorded and compared.
Measured: At 30 minutes post analgesia administration.
Median reduction in pain score at 15 minutes
Median reduction in NRS pain score at 15 minutes
Measured: 15 minutes
Median reduction in pain score at 30 minutes
Median reduction in NRS pain score at 30 minutes
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study start6 Nov 2017
- Primary completion24 May 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Emergency Health Services
- Responsible party
- Principal investigator, Gary Andolfatto, University of British Columbia
- Investigators
- Gary Andolfatto, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753114
- Sponsor's protocol ID
- H16-00554
- Acronym
- PAIN-K
- Status last verified
- Oct 2018
- First submitted
- 16 Apr 2016
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26024309McLean SA, Maio RF, Domeier RM. The epidemiology of pain in the prehospital setting. Prehosp Emerg Care. 2002 Oct-Dec;6(4):402-5. doi: 10.1080/10903120290938021.
PubMed 12385606Marinangeli 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.
PubMed 19490463Lord 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.
PubMed 19497456Jennings 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.
PubMed 20679429Chambers JA, Guly HR. The need for better pre-hospital analgesia. Arch Emerg Med. 1993 Sep;10(3):187-92. doi: 10.1136/emj.10.3.187.
PubMed 8216592Ducasse JL, Siksik G, Durand-Bechu M, Couarraze S, Valle 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.
PubMed 23406077Oglesbee S, Selde W. Nitrous oxide. New delivery of an old drug. JEMS. 2014 Apr;39(4):34-7. No abstract available.
PubMed 24779097Faddy 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. doi: 10.1136/emj.2004.020891.
PubMed 16299211Johansson J, Sjoberg J, Nordgren M, Sandstrom E, Sjoberg F, Zetterstrom 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.
PubMed 23672762Borland 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. doi: 10.1046/j.1442-2026.2002.00344.x.
PubMed 12487045Borland 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. doi: 10.1016/j.annemergmed.2006.06.016. Epub 2006 Oct 25.
PubMed 17067720Borland 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.
PubMed 19125831Holdgate 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.
PubMed 20070272Karlsen 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.
PubMed 24268523
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Analgesia With Intra-Nasal Ketamine
- ClinicalTrials.gov ID
- NCT02753114
- Acronym / sponsor ID
- PAIN-K / H16-00554
- Conditions
- Pain, Acute Pain
- Keywords
- Ketamine, Intranasal, Emergency Medical Services, Pain, Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- British Columbia Emergency Health Services
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose:
The purpose of this study is to see whether intra-nasal (IN) Ketamine (50 mg / ml) solution (Sandoz; Drug Identification Number (DIN) 02246796) administered via mucosal atomization device (LMA MAD300 Nasal TM; Wolfe Tory Medical Inc., San Diego, CA), in addition to usual care with nitrous oxide inhalation, to pre-hospital patients being transported by British Columbia Emergency Health Services (BC EHS) Basic Life Support (BLS) paramedics with moderate to severe pain (pain > 5/10 on a validated numerical rating scale or NRS) will improve pain relative to usual care plus placebo.
Hypothesis:
It is hypothesized 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 a greater proportion of patients experiencing a 2-point or more reduction in verbal numerical rating scale (VNRS) pain score within 30 minutes, as well as improved patient-reported comfort, reduced nitrous oxide requirements, and improved patient and provider satisfaction compared to usual care alone.
Background:
Acute painful conditions make-up a large proportion of pre-hospital transports yet 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 BLS pre-hospital providers. Nitrous oxide has been shown to be effective for analgesia in patients with moderate pain but its utility in severe pain is uncertain. No alternative treatments exist for BLS providers in the pre-hospital setting. Intra-nasal ketamine is a safe, well-tolerated means of providing analgesia and has been proven to work in the pre-hospital setting without the need for cardio-respiratory monitoring.
Objectives:
The objective of this study is to collect pilot data to compare the addition of intranasal Ketamine or an intranasal placebo in terms of efficacy and effectiveness in patients receiving usual care with nitrous oxide for moderate to severe pain.
Secondary objectives will be to assess subjective improvement in pain, effect on nitrous oxide requirements, incidence of adverse effects, patient and provider satisfaction, and study recruitment potential. These data will inform future large-scale trial designs and will be used to validate a proposed 7-point patient-reported pain improvement scale.
Research Methods:
This will be a randomized double-blind pilot trial conducted in the pre-hospital setting in the lower mainland. The pilot series will constitute 40 patients (20 per group). The sample size for a larger randomized controlled trial will then be calculated using the effect size and variance of the accrued data.
Statistical Analysis:
A statistician will be contracted to independently oversee the analysis of study results. The intention-to-treat principal will be used to analyze all data. Data will be analyzed using descriptive statistics. Categorical data will be presented as frequency and percentage frequency of occurrence. Continuous data will be presented as medians with ranges and interquartile ranges (IQRs). Adverse effects will be described as frequency of occurrence with 95% confidence intervals. A p-value of 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Ketamine | Experimental | Drug: KetamineKetamine dosing will be weight-based as follows: 30mg of IN ketamine for patients weighing 50 kg or less; 50 mg of IN ketamine for patients weighing 50 kg to 100 kg; and 75 mg of IN ketamine for patients weighing greater than 100 kg (i.e. 0.5 mg/kg to 1.0 mg/kg of intranasal ketamine). Syringes containing ketamine will be prepared from the intravenous formulation of Ketamine (50 mg / ml) solution (Sandoz; DIN 02246796) and stored in pre-filled 5 ml syringes. Ketamine will be administered to patients through a mucosal atomization device. One-half of the pre-specified volume will be administered into each nare. No repeat doses will be administered. |
| Placebo | Placebo comparator | Drug: Normal SalineSyringes containing normal saline will be prepared such that the volume of normal saline in 5 ml syringes matches that of the ketamine for each of the weight based groups previously specified in the Treatment Arm Description. Syringes containing normal saline will also be labeled "Study Drug". The normal saline will also be administered to patients through a mucosal atomization device. One-half of the pre-specified volume will be administered into each nare. No repeat doses of placebo will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Less than 18 years of age.
- Previous hypersensitivity, intolerance or allergy to ketamine
- Chest pain
- Altered mental status
- Inability self-report pain score
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Sandoz DIN 02246796, KetalarIntranasal Ketamine administered via mucosal atomization device at 0.5 - 1 mg / kg IN. | Drug | Intranasal Ketamine |
| Normal SalineAlso: Saline placeboIntranasal Normal Saline administered via mucosal atomization device. | Drug | Placebo |
Primary outcome
Proportion experiencing 2-point or more pain score reduction at 30 minutes
Time frame: 30 minutes.
The proportion of patients experiencing a 2-point or more reduction in NRS pain score at 30 minutes.
10 secondary outcomes
Proportion experiencing 2-point or more pain score reduction at 15 minutes
Time frame: 15 minutes
The proportion of patients feeling "a lot better" or "moderately better" at 30 minutes post medication delivery or hospital at hospital arrival
Time frame: 30 minutes
The proportion of patients feeling "a lot better" or "moderately better" at 15 minutes.
Time frame: 15 minutes
The proportion of patients feeling "a lot better", "moderately better" or "a little better" at 15 minutes and at 30 minutes.
Time frame: 15 minutes, 30 minutes
Adverse Events
Time frame: Every 15 minutes until care transferred to Emergency Department
Patient Satisfaction
Time frame: At 30 minutes post analgesia administration.
Provider Satisfaction
Time frame: At 30 minutes post analgesia administration.
Median Nitrous Oxide Consumption
Time frame: At 30 minutes post analgesia administration.
Median reduction in pain score at 15 minutes
Time frame: 15 minutes
Median reduction in pain score at 30 minutes
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Background: PubMed 26024309Murphy 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.
- Background: PubMed 12385606McLean SA, Maio RF, Domeier RM. The epidemiology of pain in the prehospital setting. Prehosp Emerg Care. 2002 Oct-Dec;6(4):402-5. doi: 10.1080/10903120290938021.
- Background: PubMed 19490463Marinangeli 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.
- Background: PubMed 19497456Lord 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.
- Background: PubMed 20679429Jennings 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.
- Background: PubMed 8216592Chambers JA, Guly HR. The need for better pre-hospital analgesia. Arch Emerg Med. 1993 Sep;10(3):187-92. doi: 10.1136/emj.10.3.187.
- Background: PubMed 23406077Ducasse JL, Siksik G, Durand-Bechu M, Couarraze S, Valle 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.
- Background: PubMed 24779097Oglesbee S, Selde W. Nitrous oxide. New delivery of an old drug. JEMS. 2014 Apr;39(4):34-7. No abstract available.
- Background: PubMed 16299211Faddy 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. doi: 10.1136/emj.2004.020891.
- Background: PubMed 23672762Johansson J, Sjoberg J, Nordgren M, Sandstrom E, Sjoberg F, Zetterstrom 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.
- Background: PubMed 12487045Borland 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. doi: 10.1046/j.1442-2026.2002.00344.x.
- Background: PubMed 17067720Borland 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. doi: 10.1016/j.annemergmed.2006.06.016. Epub 2006 Oct 25.
- British Columbia Ambulance Service information page.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Andolfatto principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Normal Saline in people with Pain and Acute Pain, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion experiencing 2-point or more pain score reduction at 30 minutes (time frame: 30 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753114, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.