Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control

Cesarean Section; Dehiscence Clinical Trial

Official title:

Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control : A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369133
• Other study ID #: KA 13-180
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2015
• Last updated: February 20, 2015
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: February 2015
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive paracetamol on postoperative pain scores, patient satisfaction, total morfin consumption and the incidence of morfin‑related side effects in patients undergoing cesarean section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients between the ages of 20-40 years,

• ASA physical status 1-2 who underwent elective cesarean surgery during general anesthesia were included in the study

Exclusion Criteria:

• A history of allergy to any of the study medications (opiod, general anesthetic agents or paracetamol),

• history of opioid or paracetamol use,

• hepatic or renal failure,

• any psychological disorders,

• complications during cesarean section and unable to use PCIA device were excluded from the study.

Study Design

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

Related Conditions & MeSH terms

• Cesarean Section; Dehiscence

Intervention

Drug:
• paracetamol
Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol, patients in group S (n = 30) received 100 ml iv %0.9 NaCl
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain scores measured by visual analog scale (VAS)		Postoperative 24 hours	Yes