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OpenTrials
Completed

NCT Number: NCT03120403

Safety and Efficacy of Intrathecal Morphine in Children

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.

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Key information

Conditions

Abdominal Cancer

Age range

3 year–12 year

Study type

Interventional

Phase

Phase 2

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrathecal Morphine

Procedure

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Alaa Ali Mohamed Elzohry

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2017
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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