IbuprofenNCT02243254
Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen
A study testing high dose remifentanil, Ibuprofen and low dose remifentanil in people with Ibuprofen and Remifentanil, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Postoperative hyperalgesia has been reported after intraoperative administration of small or high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the development of opioid-induced hyperalgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ibuprofen, Remifentanil, Hyperalgesia
- What is being tested?
- high dose remifentanil, Ibuprofen and low dose remifentanil
- 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 siteSouth Korea
- Study dates
- Jul 2014to Apr 2015
- Phase
- Interventional
- 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
- Adult patients scheduled for elective pancreaticoduodenectomy
Who cannot join
- Patients with chronic pain
- Patients with psychiatric disease
- Patients with nonsteroidal antiinflammatory drugs allergy
- Patients with renail dysfunction
- History of drug addiction
- Pregnant patient
- Inability to use a PCA device
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative hyperalgesia has been reported after intraoperative administration of small or high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the development of opioid-induced hyperalgesia. The aim of this study is to evaluate the preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia
- Conditions
- Ibuprofen, Remifentanil, Hyperalgesia, Pain, Postoperative
- Being tested
- high dose remifentanil, Ibuprofen, low dose remifentanil
- Medical subject headings
- Hyperalgesia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dose remifentanilDrug
high dose remifentanil
IbuprofenDrug
intravenous ibuprofen
low dose remifentanilDrug
low dose remifentanil
| Study group | Role | What they receive |
|---|---|---|
| high dose remifentanil without ibuprofen | Placebo comparator | remifentanil target-controlled infusion effect-site concentration 4 ng/ml normal saline before surgical incision Receives: Drug: high dose remifentanil |
| low dose remifentanil without ibuprofen | Placebo comparator | remifentanil target-controlled infusion effect-site concentration 1 ng/ml normal saline before surgical incision Receives: Drug: low dose remifentanil |
| high dose remifentanil with ibuprofen | Active comparator | remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision Receives: Drug: high dose remifentanil; Drug: Ibuprofen |
| low dose remifentanil with ibuprofen | Active comparator | remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision Receives: Drug: Ibuprofen; Drug: low dose remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative morphine consumption
cumulative patient-controlled analgesia (PCA) morphine consumption
Measured: postoperative 48 hours
Secondary outcomes (1)
Pain score
visual analogue scale
Measured: postoperative 1, 3, 6,12, 24, 48 hours Pain score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IbuprofenStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243254
- Sponsor's protocol ID
- ibuprofen_hyperalgesia
- Status last verified
- Nov 2015
- First submitted
- 15 Sep 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen
- ClinicalTrials.gov ID
- NCT02243254
- Acronym / sponsor ID
- ibuprofen_hyperalgesia
- Conditions
- Ibuprofen, Remifentanil, Hyperalgesia, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Apr 2015 (actual)
- First posted
- 17 Sep 2014 (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.
Postoperative hyperalgesia has been reported after intraoperative administration of small or high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the development of opioid-induced hyperalgesia. The aim of this study is to evaluate the preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high dose remifentanil without ibuprofen | Placebo comparator | Drug: high dose remifentanilremifentanil target-controlled infusion effect-site concentration 4 ng/ml normal saline before surgical incision |
| low dose remifentanil without ibuprofen | Placebo comparator | Drug: low dose remifentanilremifentanil target-controlled infusion effect-site concentration 1 ng/ml normal saline before surgical incision |
| high dose remifentanil with ibuprofen | Active comparator | Drug: high dose remifentanil, Drug: Ibuprofenremifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision |
| low dose remifentanil with ibuprofen | Active comparator | Drug: Ibuprofen, Drug: low dose remifentanilremifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for elective pancreaticoduodenectomy
Key exclusion criteria (7 listed)
- Patients with chronic pain
- Patients with psychiatric disease
- Patients with nonsteroidal antiinflammatory drugs allergy
- Patients with renail dysfunction
- History of drug addiction
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 |
|---|---|---|
| high dose remifentanilhigh dose remifentanil | Drug | high dose remifentanil with ibuprofen, high dose remifentanil without ibuprofen |
| Ibuprofenintravenous ibuprofen | Drug | high dose remifentanil with ibuprofen, low dose remifentanil with ibuprofen |
| low dose remifentanillow dose remifentanil | Drug | low dose remifentanil with ibuprofen, low dose remifentanil without ibuprofen |
Primary outcome
cumulative morphine consumption
Time frame: postoperative 48 hours
cumulative patient-controlled analgesia (PCA) morphine consumption
1 secondary outcome
Pain score
Time frame: postoperative 1, 3, 6,12, 24, 48 hours Pain score
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 18 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high dose remifentanil, Ibuprofen and low dose remifentanil in people with Ibuprofen and Remifentanil, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 7 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 18 Nov 2015. 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 South Korea. 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.
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?
cumulative morphine consumption (time frame: postoperative 48 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 18 Nov 2015.