Effect of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries,

Assiut University

Status: Unknown

Conditions: Major Abdominal Surgeries

Treatments: Drug: Intrathecal Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03158584

343

Details and patient eligibility

About

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).

Full 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

Enrollment: 45 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

morphine 2 μg/kg

Active Comparator group

Description:

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

Treatment:

Drug: Intrathecal Morphine

morphine 5 μg/kg

Active Comparator group

Description:

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

Treatment:

Drug: Intrathecal Morphine

morphine 10 μg/kg

Active Comparator group

Description:

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

Treatment:

Drug: Intrathecal Morphine