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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05688371
Enrollment
60
Registered
2023-01-18
Start date
2023-02-01
Completion date
2024-10-01
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Dexmedetomidine, Morphine, PCA

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.

Interventions

DRUGstandard dose morphine

Receiving 0.05 mg morphine/kg as a bolus.

DRUGlow dose morphine plus dexmedetomidine

Receiving 0.02 mg morphine/kg as a bolus dose + 0.2 microgram/kg dexmedetomidine

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative pain intensity evaluation at (0,1, 2,6,12, 24h).24 hourvisual 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

MeasureTime frameDescription
Total morphine consumption in 24h postoperative.24 hourtotal morphine dose in 24h
sedation24 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.
respiratory depression24 hourrespiratory depression, if respiratory rate less than 10 breaths/minute
nausea vomiting24 hourNausea and vomiting was recorded using a categorical scoring system (0 = none, 1 = nausea, 2 = retching, 3 = vomiting).

Countries

Egypt

Contacts

Primary ContactMariana abdelsayed Mansour, MD
mrmrsyk4@gmail.com01222960009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026