Acute PainPhase 3NCT02062879
Ketamine Patient-Controlled Analgesia for Acute Pain
A Phase 3 study testing Ketamine and Hydromorphone in people with Acute Pain and Multiple Trauma, run by University of Cincinnati at 1 site in United States.
Trial summary
This study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. Patients receiving ketamine PCA are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Multiple Trauma, Fractures
- What is being tested?
- Ketamine and Hydromorphone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age greater than or equal to 18 years
- Total Injury Severity Score greater than 9
- Functioning intravenous catheter present per standard of care
- Patient planned to receive PCA for acute pain per standard of care
- Patient ability to effectively use a PCA device as assessed by the primary attending trauma service
- Negative pregnancy test for women of childbearing age
Who cannot join
- Body mass index greater than 35
- History of active psychiatric disease
- Acute or chronic liver or renal failure
- History of heart failure or coronary artery disease
- Patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy
- Patients who abuse alcohol and are at high risk for alcohol withdrawal
Show all 11Show fewer
- Intubated patients
- Glasgow Coma Scale score less than 13, or motor subscore less than 6
- Documented allergy to ketamine, hydromorphone, or lorazepam
- Pregnancy
- Incarceration
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Ketamine Patient-Controlled Analgesia for Acute Pain in Native Airway Multiple and Orthopedic Trauma Patients: A Randomized, Active Comparator, Blinded Trial
This study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. Patients receiving ketamine PCA are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. Patients receiving ketamine are also expected to have shorter duration of supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is further expected to be associated with decreased intensive care unit and hospital lengths of stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and lower report of chronic pain syndromes.
- Conditions
- Acute Pain, Multiple Trauma, Fractures
- Being tested
- Ketamine, Hydromorphone
- Keywords
- pain, trauma
- Medical subject headings
- Acute Pain, Multiple Trauma, Fractures, Bone, Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Ketamine administered as patient-controlled analgesia.
HydromorphoneDrug
Also called Dilaudid
Hydromorphone administered as patient-controlled analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Ketamine 90mg/30 mL PCA (3 mg/mL) Receives: Drug: Ketamine |
| Hydromorphone | Active comparator | Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Daily Opioid Requirement
Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents
Measured: Participants will be followed for their entire hospital stay, an expected average of 1 week.
Secondary outcomes (2)
Breakthrough Daily Opioid Requirement
Breakthrough daily opioid requirement in milligrams of morphine equivalents/day
Measured: Participants will be followed for their entire hospital stay, an expected average of 1 week
Median Pain Score
Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.
Measured: Participants will be followed for their entire hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Withdrawals from study due to anticipated effects from study drugs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheila Takieddine, University of Cincinnati
- Investigators
- Sheila C Takieddine, Pharm.D., Principal investigator, UC HealthEric W Mueller, Pharm.D., Principal investigator, UC Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062879
- Sponsor's protocol ID
- Mueller2014
- Status last verified
- Aug 2017
- First submitted
- 11 Feb 2014
- Last updated
- 21 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Takieddine SC, Droege CA, Ernst N, Droege ME, Webb M, Branson RD, Gerlach TW, Robinson BRH, Johannigman JA, Mueller EW. Ketamine versus hydromorphone patient-controlled analgesia for acute pain in trauma patients. J Surg Res. 2018 May;225:6-14. doi: 10.1016/j.jss.2017.12.019. Epub 2018 Jan 8.
PubMed 29605036
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Patient-Controlled Analgesia for Acute Pain in Native Airway Multiple and Orthopedic Trauma Patients: A Randomized, Active Comparator, Blinded Trial
- ClinicalTrials.gov ID
- NCT02062879
- Acronym / sponsor ID
- Mueller2014
- Conditions
- Acute Pain, Multiple Trauma, Fractures
- Keywords
- pain, trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawals from study due to anticipated effects from study drugs
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Posted 21 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. Patients receiving ketamine PCA are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. Patients receiving ketamine are also expected to have shorter duration of supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is further expected to be associated with decreased intensive care unit and hospital lengths of stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and lower report of chronic pain syndromes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineKetamine 90mg/30 mL PCA (3 mg/mL) |
| Hydromorphone | Active comparator | Drug: HydromorphoneHydromorphone 6mg/30 mL PCA (0.2 mg/mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years
- Total Injury Severity Score greater than 9
- Functioning intravenous catheter present per standard of care
- Patient planned to receive PCA for acute pain per standard of care
- Patient ability to effectively use a PCA device as assessed by the primary attending trauma service
Key exclusion criteria (11 listed)
- Body mass index greater than 35
- History of active psychiatric disease
- Acute or chronic liver or renal failure
- History of heart failure or coronary artery disease
- Patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy
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: KetalarKetamine administered as patient-controlled analgesia. | Drug | Ketamine |
| HydromorphoneAlso: DilaudidHydromorphone administered as patient-controlled analgesia. | Drug | Hydromorphone |
Primary outcome
Total Daily Opioid Requirement
Time frame: Participants will be followed for their entire hospital stay, an expected average of 1 week.
Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents
2 secondary outcomes
Breakthrough Daily Opioid Requirement
Time frame: Participants will be followed for their entire hospital stay, an expected average of 1 week
Median Pain Score
Time frame: Participants will be followed for their entire hospital stay, an expected average of 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29605036Takieddine SC, Droege CA, Ernst N, Droege ME, Webb M, Branson RD, Gerlach TW, Robinson BRH, Johannigman JA, Mueller EW. Ketamine versus hydromorphone patient-controlled analgesia for acute pain in trauma patients. J Surg Res. 2018 May;225:6-14. doi: 10.1016/j.jss.2017.12.019. Epub 2018 Jan 8.
- Individual participant dataSharing planned: No
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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.
Sheila C Takieddine, Pharm.D. principal investigator
UC Health
Eric W Mueller, Pharm.D. principal investigator
UC Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine and Hydromorphone in people with Acute Pain and Multiple Trauma, run by University of Cincinnati 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 21 Sep 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Daily Opioid Requirement (time frame: Participants will be followed for their entire hospital stay, an expected average of 1 week.). 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 NCT02062879, which also lists 1 linked publication.
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 21 Sep 2017.