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Effect of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries,

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03158584
Enrollment
45
Registered
2017-05-18
Start date
2017-01-01
Completion date
2017-07-01
Last updated
2017-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Abdominal Surgeries

Brief summary

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).

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

Interventions

DRUGIntrathecal Morphine

Intrathecal administration of Morphine in children undergoing major abdominal surgeries

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
visual analog scale24 hours postoperative .0- 10 in cm score range will be used to assess pain

Secondary

MeasureTime frameDescription
rams y sedation score24 hours0-4 score will be used

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026