NCT00890942

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

5 months

First QC Date

April 26, 2009

Last Update Submit

July 22, 2011

Conditions

Morphine Adverse Reaction

Keywords

pruritusintrathecal morphine

Outcome Measures

Primary Outcomes (1)

  • efficacy of intrathecal naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section

    24 hour

Study Arms (2)

naloxone

EXPERIMENTAL
Drug: naloxone

normal saline

PLACEBO COMPARATOR
Drug: normal saline

Interventions

naloxoneDRUG

naloxone 0.4mg.(1 ml) intramuscular

Also known as: narcan
naloxone
normal salineDRUG

normal saline 1 ml IM

normal saline

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patient schedule for cesarean section ASA class 1

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology department, Siriraj Hospital, Mahidol University

Bangkok, Thailand

Location

MeSH Terms

Conditions

Pruritus

Interventions

NaloxoneSaline Solution

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Tachawan Jirativanont, MD

    Anesthesiology department ,Siriraj hopital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2009

First Posted

April 30, 2009

Study Start

May 1, 2009

Primary Completion

October 1, 2009

Study Completion

May 1, 2010

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

TH(1)