Abdominal PainNCT04698772
Patient Satisfaction With Subdissociative Dose Ketamine Versus Morphine for Emergency Department Pain Control
An observational study of Abdominal Pain, run by CHRISTUS Health at 1 site in United States.
Trial summary
The proposed research will be a single blinded (patient) randomized controlled prospective trial of adult patients receiving treatment for moderate to severe abdominal pain to test the hypothesis that patient satisfaction with pain control with Ketamine will be comparable to patient satisfaction with pain control… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Ketamine and Morphine
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 16 Nov 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study subjects include patients presenting to the Emergency Department at CHRISTUS Spohn Shoreline Hospital during a 24 month time frame. Eligible patients will be treated for acute abdominal pain.
Who may be able to join
- Be at least 18 years of age
- Initial presenting complaint of moderate to severe abdominal pain (five or higher on numerical rating scale [NRS]).
- Subjects will be enrolled into the project one (1) time only.
Who cannot join
- Under 18 years of age
- Pregnant patients
- Inability to provide written consent
- Evidence of traumatic brain injury
- Hemodynamic instability
- Procedures involving laryngeal manipulation
Show all 10Show fewer
- History of laryngeal spasm
- History of adverse reaction to Ketamine or morphine
- Patients will not be excluded if they had received pain medications prior to enrollment (ie. Received pain medication from triage, non-physician provider (NPP), or emergency medical services (EMS) prior to being seen by physician
- History of opioid use in the last week, prescription opioid use, recreational opioid use
Trial locations and contacts
1 site in 1 country.
About this study
The proposed research will be a single blinded (patient) randomized controlled prospective trial of adult patients receiving treatment for moderate to severe abdominal pain to test the hypothesis that patient satisfaction with pain control with Ketamine will be comparable to patient satisfaction with pain control using morphine when treating abdominal pain.
Read the detailed description
Informed consent will be obtained from patients presenting with chief complaint of moderate to severe abdominal pain in the emergency department who do not meet any exclusion criteria and who willingly agree to participate by signing the written consent form. Investigators will assess the patient's opioid tolerance by asking if they have use an opioid medication in the last week, prescription opioid use at home, and/or recreational opioid use. Patients in both groups will fill out the pre-treatment questionnaire, which will include demographic questions (age, sex, race, height, weight, etc.), a 10cm (100mm) VAS for pain, a 10cm (100mm) VAS to measure patient satisfaction, and a Likert Scale to measure patient satisfaction. Post-treatment survey will be given at 30 minutes after administration of medication. The physician will record whether the patient required additional pain medication after the 30 minutes, final emergency department diagnosis, and final emergency department disposition.
- Conditions
- Abdominal Pain
- Keywords
- Emergency Department, Moderate to severe pain
- Medical subject headings
- Abdominal Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Blinded study group will receive ketamine for pain control (0.3 mg/kg IV over 3-5 minutes)
MorphineDrug
Blinded study group will receive morphine 4 mg IV push over 3-5 minutes for pain control
| Study group | Role | What they receive |
|---|---|---|
| Survey Packet 1 Group | Patients who receive "Packet 1" will be in group 1, or the treatment group. In this packet will be 4 forms: the consent to participate in the study form, a pre-treatment questionnaire (VAS and other demographic information), post-treatment questionnaire (various questions, including demographic questions [age, sex, race, height, weight, etc.], a 10cm (100mm) VAS for pain, a 10cm (100mm) VAS to measure patient satisfaction, and a Likert Scale to measure patient satisfaction), and a form with specific instructions for the physicians to follow that vary depending on whether the instructions are from "Packet 1" or "Packet 2." The physician will be asked to administer a sub-dissociative dose of ketamine for pain control (0.3 mg/kg IV over 3-5 minutes). Receives: Drug: Ketamine | |
| Survey Packet 2 Group | Patients who receive "Packet 2" will be in group 2, or the control group. In this packet will be 4 forms: the consent to participate in the study form, a pre-treatment questionnaire (VAS and other demographic information), post-treatment questionnaire (various questions, including demographic questions [age, sex, race, height, weight, etc.], a 10cm (100mm) VAS for pain, a 10cm (100mm) VAS to measure patient satisfaction, and a Likert Scale to measure patient satisfaction), and a form with specific instructions for the physicians to follow that vary depending on whether the instructions are from "Packet 1" or "Packet 2."The physician will be asked to administer morphine 4 mg IV push over 3-5 minutes for pain control. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare satisfactory scores
The primary outcome parameter is to compare satisfaction scores between patients treated with morphine vs ketamine respectively.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start19 Dec 2019
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHRISTUS Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebekka Lee, DO, CHRISTUS Health
- Investigators
- Rebekka Lee, DO, Principal investigator, CHRISTUS Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698772
- Sponsor's protocol ID
- 2019-081
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 7 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigator has interest in pursuing future collaboration and grant opportunities.
Publications
Morris B, Jahangir A, Sethi, M. Patient Satisfaction: An Emerging Health Policy Issue. AAOS. June 2013. http://www.aaos.org/news/aaosnow/jun13/advocacy5.asp
Francis, J. (2018). U.S. Hospitals That Provide Superior Patient Experience Generate 50 Percent Higher Financial Performance Than Average Providers, Accenture Finds. [online] Businesswire.com. Available at: https://www.businesswire.com/news/home/20160511005122/en/U.S.-HospitalsProvide-Superior-Patient-Experience-Generate [Accessed 13 Nov. 2018].
"HospitalHCAHPS." CMS.gov Centers for Medicare & Medicaid Services, 21 Dec. 2017, www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/HospitalQualityInits/HospitalHCAHPS.html.
Berkowitz B. The Patient Experience and Patient Satisfaction: Measurement of a Complex Dynamic. Online J Issues Nurs. 2016 Jan 31;21(1):1. doi: 10.3912/OJIN.Vol21No01Man01.
PubMed 27852212Baker DW. The Joint Commission's Pain Standards: Origins and Evolution. Oakbrook Terrace, IL: The Joint Commission; 2017
Axeen S, Seabury SA, Menchine M. Emergency Department Contribution to the Prescription Opioid Epidemic. Ann Emerg Med. 2018 Jun;71(6):659-667.e3. doi: 10.1016/j.annemergmed.2017.12.007. Epub 2018 Jan 16.
PubMed 29373155Butler MM, Ancona RM, Beauchamp GA, Yamin CK, Winstanley EL, Hart KW, Ruffner AH, Ryan SW, Ryan RJ, Lindsell CJ, Lyons MS. Emergency Department Prescription Opioids as an Initial Exposure Preceding Addiction. Ann Emerg Med. 2016 Aug;68(2):202-8. doi: 10.1016/j.annemergmed.2015.11.033. Epub 2016 Feb 11.
PubMed 26875061Nsc.org. (2018). Prescription Drug Abuse. [online] Available at: https://www.nsc.org/home-safety/safety-topics/opioids [Accessed 13 Nov. 2018].
Motov S, Drapkin J, Likourezos A, Beals T, Monfort R, Fromm C, Marshall J. Continuous Intravenous Sub-Dissociative Dose Ketamine Infusion for Managing Pain in the Emergency Department. West J Emerg Med. 2018 May;19(3):559-566. doi: 10.5811/westjem.2017.12.36174. Epub 2018 Mar 8.
PubMed 29760856Karlow N, Schlaepfer CH, Stoll CRT, Doering M, Carpenter CR, Colditz GA, Motov S, Miller J, Schwarz ES. A Systematic Review and Meta-analysis of Ketamine as an Alternative to Opioids for Acute Pain in the Emergency Department. Acad Emerg Med. 2018 Oct;25(10):1086-1097. doi: 10.1111/acem.13502. Epub 2018 Jul 17.
PubMed 30019434Bowers KJ, McAllister KB, Ray M, Heitz C. Ketamine as an Adjunct to Opioids for Acute Pain in the Emergency Department: A Randomized Controlled Trial. Acad Emerg Med. 2017 Jun;24(6):676-685. doi: 10.1111/acem.13172. Epub 2017 Mar 22.
PubMed 28177167Pourmand A, Mazer-Amirshahi M, Royall C, Alhawas R, Shesser R. Low dose ketamine use in the emergency department, a new direction in pain management. Am J Emerg Med. 2017 Jun;35(6):918-921. doi: 10.1016/j.ajem.2017.03.005. Epub 2017 Mar 2.
PubMed 28285863Sin B, Tatunchak T, Paryavi M, Olivo M, Mian U, Ruiz J, Shah B, de Souza S. The Use of Ketamine for Acute Treatment of Pain: A Randomized, Double-Blind, Placebo-Controlled Trial. J Emerg Med. 2017 May;52(5):601-608. doi: 10.1016/j.jemermed.2016.12.039. Epub 2017 Mar 6.
PubMed 28279542Motov S, Rosenbaum S, Vilke GM, Nakajima Y. Is There a Role for Intravenous Subdissociative-Dose Ketamine Administered as an Adjunct to Opioids or as a Single Agent for Acute Pain Management in the Emergency Department? J Emerg Med. 2016 Dec;51(6):752-757. doi: 10.1016/j.jemermed.2016.07.087. Epub 2016 Sep 29.
PubMed 27693070Motov S, Rockoff B, Cohen V, Pushkar I, Likourezos A, McKay C, Soleyman-Zomalan E, Homel P, Terentiev V, Fromm C. Intravenous Subdissociative-Dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2015 Sep;66(3):222-229.e1. doi: 10.1016/j.annemergmed.2015.03.004. Epub 2015 Mar 26.
PubMed 25817884
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Subdissociative Dose Ketamine Versus Morphine for Emergency Department Pain Control
- ClinicalTrials.gov ID
- NCT04698772
- Acronym / sponsor ID
- 2019-081
- Conditions
- Abdominal Pain
- Keywords
- Emergency Department, Moderate to severe pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CHRISTUS HealthUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 7 Jan 2021 (actual)
- 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.
The proposed research will be a single blinded (patient) randomized controlled prospective trial of adult patients receiving treatment for moderate to severe abdominal pain to test the hypothesis that patient satisfaction with pain control with Ketamine will be comparable to patient satisfaction with pain control using morphine when treating abdominal pain.
Detailed description
Informed consent will be obtained from patients presenting with chief complaint of moderate to severe abdominal pain in the emergency department who do not meet any exclusion criteria and who willingly agree to participate by signing the written consent form. Investigators will assess the patient's opioid tolerance by asking if they have use an opioid medication in the last week, prescription opioid use at home, and/or recreational opioid use. Patients in both groups will fill out the pre-treatment questionnaire, which will include demographic questions (age, sex, race, height, weight, etc.), a 10cm (100mm) VAS for pain, a 10cm (100mm) VAS to measure patient satisfaction, and a Likert Scale to measure patient satisfaction. Post-treatment survey will be given at 30 minutes after administration of medication. The physician will record whether the patient required additional pain medication after the 30 minutes, final emergency department diagnosis, and final emergency department disposition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survey Packet 1 Group | – | Drug: KetaminePatients who receive "Packet 1" will be in group 1, or the treatment group. In this packet will be 4 forms: the consent to participate in the study form, a pre-treatment questionnaire (VAS and other demographic information), post-treatment questionnaire (various questions, including demographic questions [age, sex, race, height, weight, etc.], a 10cm (100mm) VAS for pain, a 10cm (100mm) VAS to measure patient satisfaction, and a Likert Scale to measure patient satisfaction), and a form with specific instructions for the physicians to follow that vary depending on whether the instructions are from "Packet 1" or "Packet 2." The physician will be asked to administer a sub-dissociative dose of ketamine for pain control (0.3 mg/kg IV over 3-5 minutes). |
| Survey Packet 2 Group | – | Drug: MorphinePatients who receive "Packet 2" will be in group 2, or the control group. In this packet will be 4 forms: the consent to participate in the study form, a pre-treatment questionnaire (VAS and other demographic information), post-treatment questionnaire (various questions, including demographic questions [age, sex, race, height, weight, etc.], a 10cm (100mm) VAS for pain, a 10cm (100mm) VAS to measure patient satisfaction, and a Likert Scale to measure patient satisfaction), and a form with specific instructions for the physicians to follow that vary depending on whether the instructions are from "Packet 1" or "Packet 2."The physician will be asked to administer morphine 4 mg IV push over 3-5 minutes for pain control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects include patients presenting to the Emergency Department at CHRISTUS Spohn Shoreline Hospital during a 24 month time frame. Eligible patients will be treated for acute abdominal pain.
Key inclusion criteria (3 listed)
- Be at least 18 years of age
- Initial presenting complaint of moderate to severe abdominal pain (five or higher on numerical rating scale [NRS]).
- Subjects will be enrolled into the project one (1) time only.
Key exclusion criteria (10 listed)
- Under 18 years of age
- Pregnant patients
- Inability to provide written consent
- Evidence of traumatic brain injury
- Hemodynamic instability
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 |
|---|---|---|
| KetamineBlinded study group will receive ketamine for pain control (0.3 mg/kg IV over 3-5 minutes) | Drug | Survey Packet 1 Group |
| MorphineBlinded study group will receive morphine 4 mg IV push over 3-5 minutes for pain control | Drug | Survey Packet 2 Group |
Primary outcome
Compare satisfactory scores
Time frame: 24 months
The primary outcome parameter is to compare satisfaction scores between patients treated with morphine vs ketamine respectively.
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 7 Jan 2021.
- BackgroundMorris B, Jahangir A, Sethi, M. Patient Satisfaction: An Emerging Health Policy Issue. AAOS. June 2013. http://www.aaos.org/news/aaosnow/jun13/advocacy5.asp
- BackgroundFrancis, J. (2018). U.S. Hospitals That Provide Superior Patient Experience Generate 50 Percent Higher Financial Performance Than Average Providers, Accenture Finds. [online] Businesswire.com. Available at: https://www.businesswire.com/news/home/20160511005122/en/U.S.-HospitalsProvide-Superior-Patient-Experience-Generate [Accessed 13 Nov. 2018].
- Background"HospitalHCAHPS." CMS.gov Centers for Medicare & Medicaid Services, 21 Dec. 2017, www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/HospitalQualityInits/HospitalHCAHPS.html.
- Background: PubMed 27852212Berkowitz B. The Patient Experience and Patient Satisfaction: Measurement of a Complex Dynamic. Online J Issues Nurs. 2016 Jan 31;21(1):1. doi: 10.3912/OJIN.Vol21No01Man01.
- BackgroundBaker DW. The Joint Commission's Pain Standards: Origins and Evolution. Oakbrook Terrace, IL: The Joint Commission; 2017
- Background: PubMed 29373155Axeen S, Seabury SA, Menchine M. Emergency Department Contribution to the Prescription Opioid Epidemic. Ann Emerg Med. 2018 Jun;71(6):659-667.e3. doi: 10.1016/j.annemergmed.2017.12.007. Epub 2018 Jan 16.
- Background: PubMed 26875061Butler MM, Ancona RM, Beauchamp GA, Yamin CK, Winstanley EL, Hart KW, Ruffner AH, Ryan SW, Ryan RJ, Lindsell CJ, Lyons MS. Emergency Department Prescription Opioids as an Initial Exposure Preceding Addiction. Ann Emerg Med. 2016 Aug;68(2):202-8. doi: 10.1016/j.annemergmed.2015.11.033. Epub 2016 Feb 11.
- BackgroundNsc.org. (2018). Prescription Drug Abuse. [online] Available at: https://www.nsc.org/home-safety/safety-topics/opioids [Accessed 13 Nov. 2018].
- Background: PubMed 29760856Motov S, Drapkin J, Likourezos A, Beals T, Monfort R, Fromm C, Marshall J. Continuous Intravenous Sub-Dissociative Dose Ketamine Infusion for Managing Pain in the Emergency Department. West J Emerg Med. 2018 May;19(3):559-566. doi: 10.5811/westjem.2017.12.36174. Epub 2018 Mar 8.
- Background: PubMed 30019434Karlow N, Schlaepfer CH, Stoll CRT, Doering M, Carpenter CR, Colditz GA, Motov S, Miller J, Schwarz ES. A Systematic Review and Meta-analysis of Ketamine as an Alternative to Opioids for Acute Pain in the Emergency Department. Acad Emerg Med. 2018 Oct;25(10):1086-1097. doi: 10.1111/acem.13502. Epub 2018 Jul 17.
- Background: PubMed 28177167Bowers KJ, McAllister KB, Ray M, Heitz C. Ketamine as an Adjunct to Opioids for Acute Pain in the Emergency Department: A Randomized Controlled Trial. Acad Emerg Med. 2017 Jun;24(6):676-685. doi: 10.1111/acem.13172. Epub 2017 Mar 22.
- Background: PubMed 28285863Pourmand A, Mazer-Amirshahi M, Royall C, Alhawas R, Shesser R. Low dose ketamine use in the emergency department, a new direction in pain management. Am J Emerg Med. 2017 Jun;35(6):918-921. doi: 10.1016/j.ajem.2017.03.005. Epub 2017 Mar 2.
- Individual participant dataSharing planned: Yes. The investigator has interest in pursuing future collaboration and grant opportunities.
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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.
Rebekka Lee, DO principal investigator
CHRISTUS Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Pain, run by CHRISTUS Health at 1 site in United States.
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 7 Jan 2021. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Compare satisfactory scores (time frame: 24 months). 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 NCT04698772, which also lists 23 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 7 Jan 2021.