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

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

Study Overview

• Status: Recruiting
• Conditions: Children; Dexmedetomidine; Morphine; PCA
• Intervention / Treatment: Drug: standard dose morphine; Drug: low dose morphine plus dexmedetomidine

Detailed Description

Patient-controlled analgesia (PCA) permits patients to self-administer small doses of opioid analgesics intravenously or subcutaneously at frequent intervals. PCA is used in the management of moderate-to-severe pain. Patient-controlled analgesia (PCA) is now used in children as young as 5 yr for the treatment of postoperative pain.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana AbdElsayed Mansour, MD; Phone Number: 01222960009; Email: mrmrsyk4@gmail.com

Study Locations

• Egypt
  • Egypt, Egypt
    • Recruiting
    • Benisuef university hospital
    • Contact: Mariana AbdElsayed Mansour, MD; Phone Number: 01222960009; Email: mrmrsyk4@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ASA I & II of both sex.
2. Age between 8 and 12 years.
3. Patients scheduled for exploration surgery under general anesthesia.

Exclusion Criteria:

1. Parents refused to give consent.
2. Patients with history of allergy to morphine or dexmedetomidine.
3. Mental disorders.
4. Unsuitability for extubation.
5. Comorbidities as cardiac, pulmonary and obstructive sleep apnea.
6. children with chronic opioid use for > 3 monthes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard dose morphine; children will receive 0.05 mg morphine /kg.as a bolus dose dissolved in 50 ml normal saline and 10 microgram/kg continuous infusion	Drug: standard dose morphine; Receiving 0.05 mg morphine/kg as a bolus.; Other Names: morphine sulphate
Active Comparator: low dose morphine and dexmedetomidine; children 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 .	Drug: low dose morphine plus dexmedetomidine; Receiving 0.02 mg morphine/kg as a bolus dose + 0.2 microgram/kg dexmedetomidine; Other Names: precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption in 24h postoperative.	total morphine dose in 24h	24 hour
sedation	(0 = awake; 1 = drowsy; 2 = asleep but arousable; 3 = deeply asleep). Patients were considered sedated if they had a sedation score of more than 0.	24 hour
respiratory depression	respiratory depression, if respiratory rate less than 10 breaths/minute	24 hour
nausea vomiting	Nausea and vomiting was recorded using a categorical scoring system (0 = none, 1 = nausea, 2 = retching, 3 = vomiting).	24 hour

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Mariana abdelsayed Mansour, Lecturer, Benisuef university hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: December 25, 2022
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Dexmedetomidine; Morphine
• Other Study ID Numbers: Mariana AbdElsayed Mansour

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No