Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03120403
Other study ID # intrathecal morphine
Secondary ID
Status Completed
Phase Phase 2
First received April 10, 2017
Last updated April 18, 2017
Start date July 1, 2016
Est. completion date March 30, 2017

Study information

Verified date April 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date March 30, 2017
Est. primary completion date March 30, 2017
Accepts healthy volunteers No
Gender All
Age group 3 Years to 12 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
intrathecal morphine


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alaa Ali Mohamed Elzohry

Outcome

Type Measure Description Time frame Safety issue
Primary 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 )
See also
  Status Clinical Trial Phase
Recruiting NCT03144622 - 18F-FSPG PET/CT Imaging in Patients With Cancers
Completed NCT04553471 - Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers N/A
Completed NCT02566096 - Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine Postoperatively Phase 4
Recruiting NCT05533424 - Ultrasound Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block as Postoperative Analgesia in Patients Undergoing Abdominal Cancer Surgery. Phase 3
Completed NCT04729634 - Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery N/A
Recruiting NCT00493688 - A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Completed NCT04152564 - Cardio-pulmonary and Analgesic Effects of Pre-peritoneal VS Epidural Infusion of L-bupivacaine on Abd. Cancer Patients N/A
Completed NCT03555266 - NSS-2 BRIDGE Device in Post-Operative Pain Management N/A
Withdrawn NCT04114422 - A Seven-day Preoperative Exercise Training Program in People With Abdominal Cancer N/A
Terminated NCT04199754 - IV Contrast-Enhanced Cone Beam Computed Tomography (CBCT) in Radiotherapy Early Phase 1
Recruiting NCT03063112 - Radiofrequency and Chemical Neurolysis of Thoracic Splanchnic Nerve for Abdominal Cancer Pain N/A
Completed NCT02998736 - Trial of Perioperative Tadalafil and Influenza Vaccination in Cancer Patients Undergoing Major Surgical Resection of a Primary Abdominal Malignancy Phase 1
Completed NCT00780611 - Investigating the Improvement in 4D CT Images Using AV Biofeedback
Completed NCT00415675 - Respiratory Tumor and Normal Tissue Motion N/A
Not yet recruiting NCT05903430 - A Feasibility Study of MRI Guided Stereotactic Ablative Radiotherapy (MIDSECTION)
Completed NCT03751384 - Improvement of Compliance for High Doses of EPA Amongst Patients With Colorectal Cancer N/A
Recruiting NCT05219058 - Reconstruction in Extended MArgin Cancer Surgery
Completed NCT03102619 - Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study N/A
Not yet recruiting NCT06265948 - Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia
Completed NCT05524454 - Evaluation of a Cone-beam CT Scanner for Image Guided Radiotherapy N/A