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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688371
• Other study ID #: Mariana AbdElsayed Mansour
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: March 2024

Study information

• Verified date: March 2024
• Source: Beni-Suef University
• Contact: Mariana abdelsayed Mansour, MD
• Phone: 01222960009
• Email: mrmrsyk4[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Dexmedetomidine
• Morphine
• PCA

Intervention

Drug:
• standard dose morphine
Receiving 0.05 mg morphine/kg as a bolus.
• low dose morphine plus dexmedetomidine
Receiving 0.02 mg morphine/kg as a bolus dose + 0.2 microgram/kg dexmedetomidine

Locations

Country	Name	City	State
Egypt	Benisuef University Hospital	Egypt

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total morphine consumption in 24h postoperative.	total morphine dose in 24h	24 hour
Secondary	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
Secondary	respiratory depression	respiratory depression, if respiratory rate less than 10 breaths/minute	24 hour
Secondary	nausea vomiting	Nausea and vomiting was recorded using a categorical scoring system (0 = none, 1 = nausea, 2 = retching, 3 = vomiting).	24 hour