NCT03158584

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 23, 2017

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

May 14, 2017

Last Update Submit

May 21, 2017

Conditions

Major Abdominal Surgeries

Outcome Measures

Primary Outcomes (1)

  • visual analog scale

    0- 10 in cm score range will be used to assess pain

    24 hours postoperative .

Secondary Outcomes (1)

  • rams y sedation score

    24 hours

Study Arms (3)

morphine 2 μg/kg

ACTIVE COMPARATOR

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

Drug: Intrathecal Morphine

morphine 5 μg/kg

ACTIVE COMPARATOR

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

Drug: Intrathecal Morphine

morphine 10 μg/kg

ACTIVE COMPARATOR

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

Drug: Intrathecal Morphine

Interventions

Intrathecal MorphineDRUG

Intrathecal administration of Morphine in children undergoing major abdominal surgeries

Also known as: morphine sulphate
morphine 10 μg/kgmorphine 2 μg/kgmorphine 5 μg/kg

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Children with sacral bone abnormalities
  • spina bifida
  • coagulopathy
  • mental delay or retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Institute

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Sahar A Mohamed, MD

    south egypt cancer instutite

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia,Intensive care and Pain relief

Study Record Dates

First Submitted

May 14, 2017

First Posted

May 18, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

May 23, 2017

Record last verified: 2016-07

Locations

EG(1)