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

Morphine Adverse Reaction Clinical Trial

Official title:

Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890942
• Other study ID #: Si146/2009
• Status: Completed
• Phase: N/A
• First received: April 26, 2009
• Last updated: July 22, 2011
• Start date: May 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2011
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morphine Adverse Reaction

Intervention

Drug:
• naloxone
naloxone 0.4mg.(1 ml) intramuscular
• normal saline
normal saline 1 ml IM

Locations

Country	Name	City	State
Thailand	Anesthesiology department, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of intrathecal naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section		24 hour	Yes