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

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ClinicalTrials.gov Identifier: NCT02369133
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Ozlem Ozmete, Baskent University

Brief 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.

Condition or disease Intervention/treatment Phase
Cesarean Section; Dehiscence Drug: paracetamol Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control : A Randomized Controlled Trial
Study Start Date : November 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Group Paracetamol (Group P),
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
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 Comparator: Group Saline (Group S)
Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group S (n = 30) received 100 ml iv %0,9 saline
Drug: Placebo



Primary Outcome Measures :
  1. Postoperative pain scores measured by visual analog scale (VAS) [ Time Frame: Postoperative 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Responsible Party: Ozlem Ozmete, Medical Doctor, Baskent University
ClinicalTrials.gov Identifier: NCT02369133    
Other Study ID Numbers: KA 13-180
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics