Safety and Efficacy of Intrathecal Morphine in Children

NCT03120403 | Completed Phase 2

• 1 other identifier: intrathecal morphine
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abdominal Cancer

Outcome Measures

Primary Outcomes (1)

• The face , Legs , Activity, Crying , and Consolability (FLACC) score

  The face , Legs , Activity, Crying , and Consolability (FLACC) pain score with its 0- 10 score range will be used to assess pain

  24 hours (every 4 hours )

Study Arms (3)

intrathecal morphine 2 μg/kg

ACTIVE COMPARATOR

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.

Procedure: intrathecal morphine

intrathecal morphine 5 μg/kg

ACTIVE COMPARATOR

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.

Procedure: intrathecal morphine

intrathecal morphine 10 μg/kg

ACTIVE COMPARATOR

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.

Procedure: intrathecal morphine

Interventions

intrathecal morphine PROCEDURE

intrathecal morphine 10 μg/kg; intrathecal morphine 2 μg/kg; intrathecal morphine 5 μg/kg

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alaa Ali Mohamed Elzohry: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: using opaque sealed envelopes containing computer generated randomization schedule, the opaque sealed envelopes are sequentially numbered that were open before application of anesthetic plan.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer in South Egypt Cancer Insitute

Model Details: intratehcal injection of drug( morphine).

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 19, 2017
• Study Start: July 1, 2016
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: April 19, 2017

Record last verified: 2017-04