Morphine Adverse ReactionNCT01952626
Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron
A study testing Ondansetron and Palonosetron in people with Morphine Adverse Reaction, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
Intrathecal administration of morphine is often used for control of postoperative pain. However, pruritus is one of the most common side effects of intrathecal morphine . Specific serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Morphine Adverse Reaction
- What is being tested?
- Ondansetron and Palonosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Jun 2014
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19-70 years,
- American Society of Anesthesiology physical status 1 and 2
- Scheduled for elective urologic surgery under spinal anesthesia.
Who cannot join
- Patients with cardiac and psychological problems.
- Patients who take sedatives or narcotics.
- Patient who have allergy to study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Intrathecal administration of morphine is often used for control of postoperative pain. However, pruritus is one of the most common side effects of intrathecal morphine . Specific serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.
Read the detailed description
Intrathecal administration of morphine is often used for relief of postoperative pain. However, pruritus is one of the most common side effects associated with intrathecal morphine. Specific serotonin receptor antagonists such as ondansetron could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.
- Conditions
- Morphine Adverse Reaction
- Being tested
- Ondansetron, Palonosetron
- Keywords
- intrathecal, morphine, ondansetron, palonosetron, pruritus
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called zofran
intravenous injection
PalonosetronDrug
Also called aloxi
intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| ondansetron | Active comparator | Intravenous administration of ondansetron 4mg 15 minutes before spinal anesthesia Receives: Drug: Ondansetron |
| palonosetron | Experimental | Intravenous administration of palonosetron 0.075mg 15 minutes before spinal anesthesia Receives: Drug: Palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pruritus
record of the incidence of pruritus after spinal anesthsia
Measured: 24 hours after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morphine Adverse ReactionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younghoon Jeon, Kyungpook National University Hospital
- Investigators
- Younghoon Jeon, Dr, Principal investigator, Kyungpook National University Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952626
- Sponsor's protocol ID
- KNUH 2013-03-032-001
- Status last verified
- Apr 2015
- First submitted
- 11 Jun 2013
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron
- ClinicalTrials.gov ID
- NCT01952626
- Acronym / sponsor ID
- KNUH 2013-03-032-001
- Conditions
- Morphine Adverse Reaction
- Keywords
- intrathecal, morphine, ondansetron, palonosetron, pruritus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Sep 2013 (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.
Intrathecal administration of morphine is often used for control of postoperative pain. However, pruritus is one of the most common side effects of intrathecal morphine . Specific serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.
Detailed description
Intrathecal administration of morphine is often used for relief of postoperative pain. However, pruritus is one of the most common side effects associated with intrathecal morphine. Specific serotonin receptor antagonists such as ondansetron could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ondansetron | Active comparator | Drug: OndansetronIntravenous administration of ondansetron 4mg 15 minutes before spinal anesthesia |
| palonosetron | Experimental | Drug: PalonosetronIntravenous administration of palonosetron 0.075mg 15 minutes before spinal anesthesia |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19-70 years,
- American Society of Anesthesiology physical status 1 and 2
- Scheduled for elective urologic surgery under spinal anesthesia.
Key exclusion criteria (3 listed)
- Patients with cardiac and psychological problems.
- Patients who take sedatives or narcotics.
- Patient who have allergy to study drugs.
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 |
|---|---|---|
| OndansetronAlso: zofranintravenous injection | Drug | ondansetron |
| PalonosetronAlso: aloxiintravenous injection | Drug | palonosetron |
Primary outcome
Incidence of pruritus
Time frame: 24 hours after spinal anesthesia
record of the incidence of pruritus after spinal anesthsia
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 9 Apr 2015.
Related trials for Morphine Adverse Reaction
Active, not recruitingObservational study
Side Effects of a Single Shot Intrathecal Morphine in Clinical Practice, a Retrospective Analysis
Morphine, Morphine Adverse Reaction
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.
Younghoon Jeon, Dr principal investigator
Kyungpook National University Hopsital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron and Palonosetron in people with Morphine Adverse Reaction, run by Kyungpook 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 3 inclusion and 3 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 9 Apr 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. 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?
Incidence of pruritus (time frame: 24 hours after spinal anesthesia). 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 9 Apr 2015.