Safety and Efficacy of Intrathecal Morphine in Children

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

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-03-30

Brief Summary

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Postoperative pain in pediatrics can usually be well controlled with a combination of analgesics including acetaminophen ( paracetamol) ,NSIADS, opioids , and local/regional anesthesia.The use of epidural and subarachnoid morphine for analgesia in adults has grown almost as quickly as Morton's discovery of anesthesia in 1846. The application of these techniques to the pediatric patients has evolved much more slowly,although significant progress is being made by many investigators.

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Detailed Description

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Advantage of intrathecal morphine as that extremely small doses of opioids are required when administrated intrathecally because they have direct access to spinal cord opioid receptors. Drug administered epidurally or caudally are required in much higher doses because they must first diffuse into the CSF before they reach spinal opioid receptors. As a result, the duration of action of intrathecal morphine is greater than that of single shot peridural techniques.

To investigate the 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 ,10μg/kg).

Conditions

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Abdominal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

intratehcal injection of drug( morphine).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

using opaque sealed envelopes containing computer generated randomization schedule, the opaque sealed envelopes are sequentially numbered that were open before application of anesthetic plan.

Study Groups

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intrathecal morphine 2 μg/kg

After G A and securing the tube in place , the patients will be placed in the lateral decubtious position and a single dose of intrathecal morphine will be performed using a 25 gauge needle (Brown ®,Germany) and free flow of CSF technique.children will receive intrathecal morphine 2 μg/kg in 2 ml volume normal saline.

Group Type ACTIVE_COMPARATOR

intrathecal morphine

Intervention Type PROCEDURE

intrathecal morphine 5 μg/kg

After G A and securing the tube in place , the patients will be placed in the lateral decubtious position and a single dose of intrathecal morphine will be performed using a 25 gauge needle (Brown ®,Germany) and free flow of CSF technique. children will receive intrathecal morphine 5 μg/kg in 2 ml volume normal saline.

Group Type ACTIVE_COMPARATOR

intrathecal morphine

Intervention Type PROCEDURE

intrathecal morphine 10 μg/kg

After G A and securing the tube in place , the patients will be placed in the lateral decubtious position and a single dose of intrathecal morphine will be performed using a 25 gauge needle (Brown ®,Germany) and free flow of CSF technique.children will receive intrathecal morphine 10 μg/kg in 2 ml volume normal saline.

Group Type ACTIVE_COMPARATOR

intrathecal morphine

Intervention Type PROCEDURE

Interventions

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intrathecal morphine

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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 , expected to last more than 90 minutes under general anesthesia combined with intratehcal morphine.

Exclusion Criteria

* Children with sacral bone abnormalities ,spina bifida , coagulopathy , mental delay or retardation , known allergy to the study drugs , and local infection at the site of injection will be excluded from the study.

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

Accepts Healthy Volunteers

No