Effect of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries,

May 21, 2017 updated by: Sahar Abdel Baky Mohamed, Assiut University

Safety and Efficacy of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries, Dose-finding Clinical Study

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • South Egypt Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: morphine 2 μg/kg
Children will receive intrathecal morphine 2 μg/kg in 2 ml volume normal saline.
Drug: Intrathecal Morphine
Intrathecal administration of Morphine in children undergoing major abdominal surgeries
Other Names:
  • morphine sulphate
ACTIVE_COMPARATOR: morphine 5 μg/kg
Children will receive intrathecal morphine 5 μg/kg in 2 ml volume normal saline.
Drug: Intrathecal Morphine
Intrathecal administration of Morphine in children undergoing major abdominal surgeries
Other Names:
  • morphine sulphate
ACTIVE_COMPARATOR: morphine 10 μg/kg
Children will receive intrathecal morphine 10 μg/kg in 2 ml volume normal saline.
Drug: Intrathecal Morphine
Intrathecal administration of Morphine in children undergoing major abdominal surgeries
Other Names:
  • morphine sulphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analog scale
Time Frame: 24 hours postoperative .
0- 10 in cm score range will be used to assess pain
24 hours postoperative .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rams y sedation score
Time Frame: 24 hours
0-4 score will be used
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Sahar A Mohamed, MD, south egypt cancer instutite

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

May 14, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (ACTUAL)

May 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 21, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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