Morphine Adverse ReactionNCT00890942
Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal Morphine Induced Pruritus After Cesarean Section
A study testing naloxone and normal saline in people with Morphine Adverse Reaction, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether intramuscular naloxone 0.4mg. is effective in prophylaxis of intrathecal morphine induced pruritus after cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Morphine Adverse Reaction
- What is being tested?
- naloxone and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- May 2009to May 2010
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patient schedule for cesarean section ASA class 1
Who cannot join
- have contraindication for spinal block
- complicated pregnancy
- have history of drug abuse during pregnancy
- obesity BMI>35kg./m2
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Anesthesiology department, Siriraj Hospital, Mahidol University
Bangkok
About this study
Official title: Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal
The purpose of this study is to determine whether intramuscular naloxone 0.4mg. is effective in prophylaxis of intrathecal morphine induced pruritus after cesarean section.
- Conditions
- Morphine Adverse Reaction
- Being tested
- naloxone, normal saline
- Keywords
- pruritus, intrathecal morphine
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naloxoneDrug
Also called narcan
naloxone 0.4mg.(1 ml) intramuscular
normal salineDrug
normal saline 1 ml IM
| Study group | Role | What they receive |
|---|---|---|
| naloxone | Experimental | Not described Receives: Drug: naloxone |
| normal saline | Placebo comparator | Not described Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of intrathecal naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionMay 2010
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.
- More trials run by Mahidol UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Tachawan Jirativanont, MD, Principal investigator, Anesthesiology department ,Siriraj hopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890942
- Sponsor's protocol ID
- Si146/2009
- Status last verified
- Jul 2011
- First submitted
- 26 Apr 2009
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal
- ClinicalTrials.gov ID
- NCT00890942
- Acronym / sponsor ID
- Si146/2009
- Conditions
- Morphine Adverse Reaction
- Keywords
- pruritus, intrathecal morphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Apr 2009 (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.
The purpose of this study is to determine whether intramuscular naloxone 0.4mg. is effective in prophylaxis of intrathecal morphine induced pruritus after cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| naloxone | Experimental | Drug: naloxone |
| normal saline | Placebo comparator | Drug: normal saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patient schedule for cesarean section ASA class 1
Key exclusion criteria (4 listed)
- have contraindication for spinal block
- complicated pregnancy
- have history of drug abuse during pregnancy
- obesity BMI>35kg./m2
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 |
|---|---|---|
| naloxoneAlso: narcannaloxone 0.4mg.(1 ml) intramuscular | Drug | naloxone |
| normal salinenormal saline 1 ml IM | Drug | normal saline |
Primary outcome
efficacy of intrathecal naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section
Time frame: 24 hour
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 25 Jul 2011.
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.
Tachawan Jirativanont, MD principal investigator
Anesthesiology department ,Siriraj hopital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing naloxone and normal saline in people with Morphine Adverse Reaction, run by Mahidol University at 1 site in Thailand.
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 4 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 25 Jul 2011. 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 Thailand. 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?
efficacy of intrathecal naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section (time frame: 24 hour). 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 25 Jul 2011.