Safety and Efficacy of Intrathecal Morphine in Children

Phase 2

Completed

• Conditions: Abdominal Cancer
• Interventions: Procedure: intrathecal morphine

• Registration Number: NCT03120403
• Lead Sponsor: Alaa Ali Mohamed Elzohry

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-03-30
• Study Completion: 2017-03-30
• Status Verified: 2017-04
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Study First Posted: 2017-04-19
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intrathecal morphine 2 μg/kg	intrathecal morphine	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.
intrathecal morphine 5 μg/kg	intrathecal morphine	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.
intrathecal morphine 10 μg/kg	intrathecal morphine	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.

Primary Outcome Measures

Name	Time	Method
The face , Legs , Activity, Crying , and Consolability (FLACC) score	24 hours (every 4 hours )	The face , Legs , Activity, Crying , and Consolability (FLACC) pain score with its 0- 10 score range will be used to assess pain