Prehospital Analgesia With Intra-Nasal Ketamine

Pain Clinical Trial

— PAIN-K  

Official title:

Prehospital Analgesia With Intra-Nasal Ketamine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753114
• Other study ID #: H16-00554
• Status: Completed
• Phase: Phase 4
• Start date: November 6, 2017
• Est. completion date: May 24, 2018

Study information

• Verified date: October 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Drug:
• Ketamine
Intranasal Ketamine administered via mucosal atomization device at 0.5 - 1 mg / kg IN.
• Normal Saline
Intranasal Normal Saline administered via mucosal atomization device.

Locations

Country	Name	City	State
Canada	British Columbia Emergency Health Services Station 249	Surrey	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Emergency Health Services

Country where clinical trial is conducted

Canada, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

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

External Links

•   British Columbia Ambulance Service information page.