Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal Morphine Induced Pruritus After Cesarean Section

NCT ID: NCT00890942

Last Updated: 2011-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Morphine Adverse Reaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

naloxone

Group Type EXPERIMENTAL

naloxone

Intervention Type DRUG

naloxone 0.4mg.(1 ml) intramuscular

normal saline

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

normal saline 1 ml IM

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

naloxone

naloxone 0.4mg.(1 ml) intramuscular

Intervention Type DRUG

normal saline

normal saline 1 ml IM

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

narcan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patient schedule for cesarean section ASA class 1

Exclusion Criteria

* have contraindication for spinal block
* complicated pregnancy
* have history of drug abuse during pregnancy
* obesity BMI\>35kg./m2
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mahidol University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tachawan Jirativanont, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology department ,Siriraj hopital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anesthesiology department, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Si146/2009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.