NCT03120403

Safety and Efficacy of Intrathecal Morphine in Children

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Alaa Ali Mohamed Elzohry · Academic / Other
• Sex: —
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Abdominal Cancer

Interventions

Type	Name	Description
PROCEDURE	intrathecal morphine

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-03-30
• Completion: 2017-03-30
• First posted: 2017-04-19
• Last updated: 2017-04-19