To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand

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

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-06-30

Brief Summary

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Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols: (1) pain relievers' administration in fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration following demand (the same type and doses, however, medications will be given only following patient's request).

The primary outcome will be patient satisfaction, pain control and the necessity of additional medications (rescue doses).

The protocols will be used for the first 48 hours following surgery.

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Detailed Description

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Conditions

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Pain Management Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fix protocol

During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication):

At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams

After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams).

After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams.

Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day.

The total amount of paracetamol is limited to 4 gr per day.

Group Type EXPERIMENTAL

Fix protocol

Intervention Type DRUG

Please see arm description

medications following demand protocol

The same combinations will be given as in the fixed protocol however only after patient request

Group Type EXPERIMENTAL

medications following demand protocol

Intervention Type DRUG

Please see arm description

Interventions

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Fix protocol

Please see arm description

Intervention Type DRUG

medications following demand protocol

Please see arm description

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* women that underwent cesarean section

Exclusion Criteria

* Women suffering from chronic pain
* Women using chronic pain medications
* Allergy to any drug used in the study
* Women underwent general anesthesia during the surgery
* women with elevated liver enzymes

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes