Dexmedetomidine Plus Low Dose Morphine Versus Standard Dose of Morphine in PCA in Children .
Comparison of Addition of Dexmedetomidine to Low Dose Morphine Versus Standard Dose of Morphine in Patiant Controlled Analgesia in Children Undergoing Pelvi Abdominal Exploration. a Prospective Randomized Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
The treatment of perioperative pain in children has been a topic of great interest to pediatricians, pediatric surgeons, and anesthesiologists for many years. Opioids are the most common analgesics used to manage acute postoperative pain in children and adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedSeptember 25, 2024
March 1, 2024
1.7 years
December 25, 2022
September 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative pain intensity evaluation at (0,1, 2,6,12, 24h).
visual analogue score consists of a straight 10 cm line with the end points defining extreme limits between (0) no pain and (10) worst pain, the score is determined by measuring the distance between no pain and worst pain.
24 hour
Secondary Outcomes (4)
Total morphine consumption in 24h postoperative.
24 hour
sedation
24 hour
respiratory depression
24 hour
nausea vomiting
24 hour
Study Arms (2)
standard dose morphine
ACTIVE COMPARATORchildren will receive 0.05 mg morphine /kg.as a bolus dose dissolved in 50 ml normal saline and 10 microgram/kg continuous infusion
low dose morphine and dexmedetomidine
ACTIVE COMPARATORchildren will receive 0.02 mg morphine /kg bolus dose plus 0.2 µg/kg dexmedetomidine dissolved in 50 ml normal saline and10 microgram/kg continuous infusion .
Interventions
Receiving 0.05 mg morphine/kg as a bolus.
Receiving 0.02 mg morphine/kg as a bolus dose + 0.2 microgram/kg dexmedetomidine
Eligibility Criteria
You may qualify if:
- ASA I \& II of both sex.
- Age between 8 and 12 years.
- Patients scheduled for exploration surgery under general anesthesia.
You may not qualify if:
- Parents refused to give consent.
- Patients with history of allergy to morphine or dexmedetomidine.
- Mental disorders.
- Unsuitability for extubation.
- Comorbidities as cardiac, pulmonary and obstructive sleep apnea.
- children with chronic opioid use for \> 3 monthes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Benisuef University Hospital
Egypt, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariana abdelsayed Mansour, Lecturer
Benisuef university hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Benisuef university
Study Record Dates
First Submitted
December 25, 2022
First Posted
January 18, 2023
Study Start
February 1, 2023
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
September 25, 2024
Record last verified: 2024-03