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

Sponsor
Beni-Suef University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05688371
Collaborator
(none)
46
Enrollment
2
Arms
5
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: standard dose morphine
  • Drug: low dose morphine plus dexmedetomidine
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: standard dose morphine

children will receive 0.05 mg morphine /kg.as a bolus dose followed by 0.05 mg/kg/hr morphine continous infusion dissolved in 100 ml normal saline with lockout interval of 15 min.PCA bolus dose 1 ml (0.5 mg morphine).

Drug: standard dose morphine
Receiving 0.05 mg morphine /kg as a bolus dose followed by 0.05 mg/kg/hr morphine continous infusion dissolved in 100 ml normal saline with lockout interval of 15 min.PCA bolus dose 0.5mg morphine.
Other Names:
  • morphine sulphate

    		•
    Active Comparator: low dose morphine plus dexmedetomidine

    children will receive 0.05 mg morphine /kg bolus dose followed by 0.02mg/kg/hr plus 0.2 µg/kg dexmedetomidine in 100 ml normal saline with lockout interval of 15 min.PCA bolus dose 1 ml (0.2 mg + 2 mic dexmedetomidine)

    Drug: low dose morphine plus dexmedetomidine
    Receiving 0.05 mg morphine /kg bolus dose followed by 0.02mg/kg/hr plus 0.2 µg/kg dexmedetomidine continous infusion in 100 ml normal saline with lockout interval of 15 min.PCA bolus dose 0.2mg morphine + 2 microgram dexmedetomidine.
    Other Names:
  • precedex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post-operative pain intensity evaluation at (1, 2, 3, 4, 16, 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

    1. Total morphine consumption in 24h postoperative. [24 hour]

      total morphine dose in 24h

    2. 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.

    3. respiratory depression [24 hour]

      respiratory depression, if respiratory rate less than 10 breaths/minute

    4. nausea vomiting [24 hour]

      Nausea and vomiting was recorded using a categorical scoring system (0 = none, 1 = nausea, 2 = retching, 3 = vomiting).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mariana Soliman, Benisuef university, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05688371
    Other Study ID Numbers:
    • Mariana AbdElsayed Mansour
    First Posted:
    Jan 18, 2023
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dexmedetomidine
    Morphine

    Study Results

    No Results Posted as of Jan 18, 2023