Analgesic Effects of Intravenous Paracetamol on Labor Pain

Labor Pain Clinical Trial

Official title:

Analgesic Effects of Intravenous Acetaminophen on Labor Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394731
• Other study ID #: RC08-052
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2011
• Last updated: July 13, 2011
• Start date: December 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether intravenous paracetamol is effective in treating labor pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical class I-II

• term patients (= 37 weeks of gestation)

Exclusion Criteria:

• previous cesarean section

• hypertension, pre-eclampsia, eclampsia

• intra-uterine growth retardation

• intrauterine fetal death

• morbid obesity (body mass index = 35)

• allergy to any of the study drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Acetaminophen

• Meperidine

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz Medical City	Riyadh	Central

Sponsors (2)

Lead Sponsor	Collaborator
King Abdulaziz University	King Abdulaziz Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (VAS) score for pain	Patients who give written informed consent to participate will be entered into the study. Their VAS score will be determined every hour from the time of randomization until delivery of the baby. This time will vary from one patient to another depending on the duration of labor.	Up to 24 hours	No