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

NCT ID: NCT02369133

Last Updated: 2015-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cesarean Section; Dehiscence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Ozlem Ozmete

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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KA 13-180

Identifier Type: -

Identifier Source: org_study_id

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