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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Addition of Dexmedetomidine to Low Dose Morphine Versus Standard Dose of Morphine in Patiant Controlled Analgesia in Children Undergoing Pelvi Abdominal Exploration.

Conditions
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PCA, Children, Dexmedetomidine, Morphine

Intervention / Treatment
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* Drug: standard dose morphine
* Drug: low dose morphine plus dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I & II of both sex. Age between 5 and 12 years. Patients scheduled for exploration surgery under general anesthesia. Exclusion Criteria: Parents refused to give consent. Patients with history of allergy to morphine or dexmedetomidine. Mental disorders. Unsuitability for extubation. Comorbidities as cardiac, pulmonary and obstructive sleep apnea.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard dose morphine<br>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<br>* 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.<br>* Other names: morphine sulphate;|
| Active Comparator: low dose morphine plus dexmedetomidine<br>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<br>* 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.<br>* Other names: precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain intensity evaluation at (1, 2, 3, 4, 16, 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 Outcome Measures

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