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

B

Beni-Suef University

Status

Enrolling

Conditions

Morphine
Dexmedetomidine
Children
PCA

Treatments

Drug: low dose morphine plus dexmedetomidine
Drug: standard dose morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT05688371
Mariana AbdElsayed Mansour

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

8 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

standard dose morphine
Active Comparator group
Description:
children will receive 0.05 mg morphine /kg.as a bolus dose dissolved in 50 ml normal saline and 10 microgram/kg continuous infusion
Treatment:
Drug: standard dose morphine
low dose morphine and dexmedetomidine
Active Comparator group
Description:
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 .
Treatment:
Drug: low dose morphine plus dexmedetomidine

Trial contacts and locations

1

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Central trial contact

Mariana abdelsayed Mansour, MD

Data sourced from clinicaltrials.gov

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