Dexmedetomidine Plus Low Dose Morphine Versus Standard Dose of Morphine in PCA in Children .

Not Applicable

Recruiting

• Conditions: PCA; Children; Dexmedetomidine; Morphine
• Interventions: Drug: standard dose morphine; Drug: low dose morphine plus dexmedetomidine

• Registration Number: NCT05688371
• Lead Sponsor: Beni-Suef University

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

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 Timeline

• Study First Submitted: 2022-12-25
• Study First Submitted QC: 2023-01-15
• Study First Posted: 2023-01-18
• Study Start: 2023-02-01
• Status Verified: 2024-03
• Primary Completion: 2024-03
• Study Completion: 2024-03
• Last Update Submitted: 2024-03-09
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard dose morphine	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
low dose morphine and dexmedetomidine	low dose morphine plus 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 .

Primary Outcome Measures

Name	Time	Method
Post-operative pain intensity evaluation at (0,1, 2,6,12, 24h).	24 hour	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.

Secondary Outcome Measures

Name	Time	Method
Total morphine consumption in 24h postoperative.	24 hour	total morphine dose in 24h
respiratory depression	24 hour	respiratory depression, if respiratory rate less than 10 breaths/minute
nausea vomiting	24 hour	Nausea and vomiting was recorded using a categorical scoring system (0 = none, 1 = nausea, 2 = retching, 3 = vomiting).
sedation	24 hour	(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.

Trial Locations

Locations (1)

Benisuef University Hospital; 🇪🇬 Egypt, Egypt