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Effect of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries,

NCT ID: NCT03158584

Last Updated: 2017-05-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-07-01

Brief Summary

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safety and efficacy of intrathecal morphine in post operative pain relief in pediatric patients undergoing major abdominal cancer surgeries using different doses of intrathecal morphine (2 μg/kg , 5 μg/kg ,10 μg/kg).

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Detailed Description

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After obtaining approval of the local ethics committee of faculty of medicine, Assiut University , Assiut , Egypt , and parent's written informed consent, This randomized double -blinded prospective study conducted on ( 45 ) pediatric patients aged 3-12 years , weighting between 10-30 kg , and of American Society of Anesthesiologists (ASA) physical status I and II scheduled for major abdominal surgeries

Conditions

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Major Abdominal Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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morphine 2 μg/kg

Children will receive intrathecal morphine 2 μg/kg in 2 ml volume normal saline.

Group Type ACTIVE_COMPARATOR

Intrathecal Morphine

Intervention Type DRUG

Intrathecal administration of Morphine in children undergoing major abdominal surgeries

morphine 5 μg/kg

Children will receive intrathecal morphine 5 μg/kg in 2 ml volume normal saline.

Group Type ACTIVE_COMPARATOR

Intrathecal Morphine

Intervention Type DRUG

Intrathecal administration of Morphine in children undergoing major abdominal surgeries

morphine 10 μg/kg

Children will receive intrathecal morphine 10 μg/kg in 2 ml volume normal saline.

Group Type ACTIVE_COMPARATOR

Intrathecal Morphine

Intervention Type DRUG

Intrathecal administration of Morphine in children undergoing major abdominal surgeries

Interventions

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Intrathecal Morphine

Intrathecal administration of Morphine in children undergoing major abdominal surgeries

Intervention Type DRUG

Other Intervention Names

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morphine sulphate

Eligibility Criteria

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Inclusion Criteria

* weight between 10-30 kg ,
* American Society of Anesthesiologists (ASA) I - II
* major abdominal surgeries

Exclusion Criteria

* Children with sacral bone abnormalities
* spina bifida
* coagulopathy
* mental delay or retardation
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sahar Abdel Baky Mohamed

Assistant Professor of Anesthesia,Intensive care and Pain relief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sahar A Mohamed, MD

Role: PRINCIPAL_INVESTIGATOR

south egypt cancer instutite

Locations

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South Egypt Cancer Institute

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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343

Identifier Type: -

Identifier Source: org_study_id

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