Dexamethasone or Clonidine as Adjuncts to Ropivacaine for Caudal Analgesia on Analgesia Duration in Children

Study Overview
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Brief Summary
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Comparing the duration of pain relief from caudal analgesia when adjuncts like dexamethasone, clonidine, or saline (salt water) are added to ropivacaine.

Detailed Description
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The local anesthetic, which is currently used for caudal analgesia, is called ropivacaine. It works well and is safe in infants and children. Doctors commonly add small amounts of other medication to ropivacaine to prolong the duration of pain relief provided by a single injection of caudal analgesia. In this study, the length of duration of pain relief the child receives from caudal analgesia will be examined when different medications are added to ropivacaine. Specifically, dexamethasone, clonidine, or saline (salt water) will be added to ropivicaine and the length of time it takes before the child needs more pain medication will be determined. Clonidine has been added to caudal analgesia for infants and children for many years. It increases the duration of pain relieving effect of ropivicaine by itself, however, it may lead to prolonged sedation following the surgical procedure (an undesired effect) and it is expensive. Dexamethasone has been used for adult epidurals and nerve blocks and in spine surgeries. It prolongs the duration of pain relief and causes less sedation. It is commonly administered to children during surgery to help decrease nausea and vomiting after surgery. It is also much cheaper than clonidine.

Official Title
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Effect of Dexamethasone or Clonidine When Given as Adjuncts to Ropivacaine for Caudal Analgesia on Duration of Analgesia Compared to Placebo in Children

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Clonidine
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject will receive presurgical caudal block American Society of Anesthesiologists (ASA) 1 or 2 Day surgery unit weight 30 kg or less Exclusion Criteria: Neuromuscular disease Back problem Caudal area skin infection Mental retardation Developmental delay Bleeding disorder

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Dexamethasone has been used for adult epidurals and nerve blocks and in spine surgeries. It prolongs the duration of pain relief and causes less sedation. It is commonly administered to children during surgery to help decrease nausea and vomiting after surgery. It is also much cheaper than clonidine The patient will receive Ropivacaine plus 200 μgm/kg of dexamethasone in 1 ml saline | Drug: Dexamethasone<br>* 200 μgm/kg of dexamethasone in 1 ml saline<br>|
| Active Comparator: Clonidine<br>Clonidine has been added to caudal analgesia for infants and children for many years. It increases the duration of pain relief of ropivicaine by itself, however, it may lead to prolonged sedation following the surgical procedure (an undesired effect) and it is expensive. The patient will receive Ropivacaine plus 2 μg/kg of clonidine in 1 ml saline. | Drug: Clonidine<br>* 2 μg/kg of clonidine in 1 ml saline<br>|
| Placebo Comparator: Normal Saline<br>The patient only will receive Ropivacaine | Drug: Normal Saline<br>* 1 ml of saline added to the ropivacaine, 0.2%, 1 ml/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of block | Duration of block is calculated from time of first pain medication minus time of caudal placement. Caudal placement occurs before pain medication is administered. | Within 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of children between the groups who received pain medication in the PACU |  | Within 24 hours after surgery | 
| Number of children between the groups who received pain medication after hospital discharge |  | Within 24 hours after surgery | 
| number of children group between the groups who required pain medication in first 24 h after surgery |  | Within 24 hours after surgery | 
| Awakening time | Awakening time is calculated from the end of anesthesia to time to reach Steward Score of 6. Patients who are awake, coughing/crying, and have purposeful movements are assigned a Steward Score of 6. | Within 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, caudal analgesia, ropivacaine, clonidine, dexamethasone