HealthyPhase 2NCT00693160
Effect of Spinal Ketorolac After Acute Opioid Exposure
A Phase 2 study testing ketorolac, remifentanil and Capsaicin in people with Healthy, run by Wake Forest University at 1 site in United States.
Trial summary
This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ketorolac, remifentanil and Capsaicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jan 2011
- Phase
- Phase 2
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- American Society of Anesthesiologist (ASA) I or II classification
- between the ages of 18-55
- weigh less than 250 pounds
- without chronic pain
Who cannot join
- taking analgesics in the last 2 weeks
- positive urine drug screen
- pregnancy
- currently taking any prescription antidepressants or other medications that are mood altering
- liver or kidney disease
- stomach ulcers
- allergies to ketorolac, lidocaine, or capsaicin cream
- lung disease (COPD)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity Following Acute Opioid Exposure
This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medication in this study may have a role in better treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in the back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. The sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. This study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. The investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous [IV] narcotic painkiller):
- How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream?
- What pain relieving effects does spinal ketorolac have when given with IV remifentanil?
Read the detailed description
Intravenous (IV) remifentanil stimulates spinal COX activity, leading to increased Cerebrospinal fluid CSF) prostaglandin E2 (PGE2) concentrations and areas of capsaicin-induced mechanical hypersensitivity after remifentanil infusion, and these effects will be blocked by intrathecal ketorolac.
Areas of mechanical hyperalgesia and allodynia will be established by topical capsaicin + intermittent heat in healthy volunteers, who will be randomized to receive intrathecal saline or ketorolac during remifentanil infusion, with primary outcome measure area of hyperalgesia and secondary outcome measure Cerebrospinal fluid (CSF) prostaglandin E2 (PGE2) concentration after stopping remifentanil.
- Conditions
- Healthy
- Being tested
- ketorolac, placebo, remifentanil, Capsaicin
- Keywords
- healthy volunteers, analgesia, pain, Healthy subjects
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketorolacDrug
Also called toradol, acular pf
single intrathecal injection of ketorolac 2 mg
placeboDrug
subject will receive a placebo (preservative free normal saline) spinal injection
remifentanilDrug
Also called ultiva
All subjects will receive a remifentanil infusion
CapsaicinDrug
Topical capsaicin pain model utilized for each subject
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Ketorolac | Experimental | In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment. Receives: Drug: ketorolac; Drug: remifentanil; Drug: Capsaicin |
| Placebo intrathecal injection | Placebo comparator | In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline) Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment. Receives: Drug: placebo; Drug: remifentanil; Drug: Capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperalgesia
Total Area of hypersensitivity (measured in centimeters) were assessed approximately 24 hours post intrathecal ketorolac injection by the method of using a von Frey filament
Measured: 24 hours
Secondary outcomes (1)
Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration
Concentration of prostaglandin E2 (PGE2) in Cerebrospinal fluid (CSF) 2.5 hours post injection of intrathecal ketorolac
Measured: 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2010
- Study completionJan 2011
Why it stopped: the manufacturing of preservative free ketorolac (Acular-PF) was discontinued
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.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- James C. Eisenach, M.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693160
- Sponsor's protocol ID
- IRB00002457
- Other IDs
- GM48085
- Status last verified
- Aug 2018
- First submitted
- 15 Feb 2008
- Last updated
- 7 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity Following Acute Opioid Exposure
- ClinicalTrials.gov ID
- NCT00693160
- Acronym / sponsor ID
- IRB00002457
- Conditions
- Healthy
- Keywords
- healthy volunteers, analgesia, pain, Healthy subjects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the manufacturing of preservative free ketorolac (Acular-PF) was discontinued
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Dec 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Posted 14 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medication in this study may have a role in better treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in the back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. The sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. This study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. The investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous [IV] narcotic painkiller):
- How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream?
- What pain relieving effects does spinal ketorolac have when given with IV remifentanil?
Detailed description
Intravenous (IV) remifentanil stimulates spinal COX activity, leading to increased Cerebrospinal fluid CSF) prostaglandin E2 (PGE2) concentrations and areas of capsaicin-induced mechanical hypersensitivity after remifentanil infusion, and these effects will be blocked by intrathecal ketorolac.
Areas of mechanical hyperalgesia and allodynia will be established by topical capsaicin + intermittent heat in healthy volunteers, who will be randomized to receive intrathecal saline or ketorolac during remifentanil infusion, with primary outcome measure area of hyperalgesia and secondary outcome measure Cerebrospinal fluid (CSF) prostaglandin E2 (PGE2) concentration after stopping remifentanil.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Ketorolac | Experimental | Drug: ketorolac, Drug: remifentanil, Drug: CapsaicinIn the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment. |
| Placebo intrathecal injection | Placebo comparator | Drug: placebo, Drug: remifentanil, Drug: CapsaicinIn the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline) Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy
- American Society of Anesthesiologist (ASA) I or II classification
- between the ages of 18-55
- weigh less than 250 pounds
- without chronic pain
Key exclusion criteria (8 listed)
- taking analgesics in the last 2 weeks
- positive urine drug screen
- pregnancy
- currently taking any prescription antidepressants or other medications that are mood altering
- liver or kidney disease
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 |
|---|---|---|
| ketorolacAlso: toradol, acular pfsingle intrathecal injection of ketorolac 2 mg | Drug | Intrathecal Ketorolac |
| placebosubject will receive a placebo (preservative free normal saline) spinal injection | Drug | Placebo intrathecal injection |
| remifentanilAlso: ultivaAll subjects will receive a remifentanil infusion | Drug | Intrathecal Ketorolac, Placebo intrathecal injection |
| CapsaicinTopical capsaicin pain model utilized for each subject | Drug | Intrathecal Ketorolac, Placebo intrathecal injection |
Primary outcome
Hyperalgesia
Time frame: 24 hours
Total Area of hypersensitivity (measured in centimeters) were assessed approximately 24 hours post intrathecal ketorolac injection by the method of using a von Frey filament
1 secondary outcome
Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration
Time frame: 2.5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James C. Eisenach, M.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ketorolac, remifentanil and Capsaicin in people with Healthy, run by Wake Forest University 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 5 inclusion and 8 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 7 Sep 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 14 Apr 2014). 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?
Hyperalgesia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2018.