Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia.

Study Overview
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Brief Summary
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The aim of this study is to compare the duration of postoperative analgesia, and any side effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in pediatric patients undergoing thoracic surgeries.

Detailed Description
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The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups: Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using morphine with bupivacaine. Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.

Official Title
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Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia for Pediatric Thoracic Surgeries. A Randomized Controlled Trial.

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I, II, III. Patients undergoing lung cyst excision. Patients undergoing Patent Ductus Arteriosus ligation. Exclusion Criteria: Preoperative mechanical ventilation. Preoperative inotropic support History of mental retardation or delayed development that may interfere with pain intensity assessment Known or suspected coagulopathy, Any congenital anomalies of the sacrum or any infection at the site of injection. Known or suspected allergy to any of the studied drugs.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine group<br>A group which will receive dexamedetomidine as an adjunct to bupivacaine used in caudal anesthesia. | Drug: Dexmedetomidine<br>* Caudal block with Dexametomedine as an adjuvant to bupivacaine.<br>* Other names: Precedex;|
| Experimental: Morphine group<br>A group which will receive morphine as an adjunct to bupivacaine used in caudal anesthesia. | Drug: Morphine<br>* Addition of morphine as adjuvant to bupivacaine during caudal block.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative analgesia in hours. | Duration of postoperative analgesia in hours. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption in the first 24 hours post- operative. | Opioid consumption in the first 24 hours post- operative. | 3 months | 
| The duration of ICU stay in days | The duration of ICU stay in days | 3 months | 
| Pain score FLACC from 0 to 6 | Pain score FLACC from 0 to 6 | 3 months | 
| Post operative heart rate | Postoperative heart rate in beat per minute | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracic surgeries, pediatric caudal, dexmedetomidine