Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?

Study Overview
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Brief Summary
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Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. However, the caudal block is a neuraxial block that has a limitation in its duration with single shot and shows complications and adverse effects. In recent studies, the pudendal nerve block has been suggested as an alternative method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer duration compared to the caudal block, decreased the use of analgesics within 24 hours after surgery, and showed higher parental satisfaction. On the other hand, there have been many studies to prolong the duration of the relatively short duration of caudal block. Among them, dexamethasone administered intravenously is known to improve the duration of various regional blocks and reduce the administration of additional analgesics. The aim of this study is to verify whether a single administration of dexamethasone can enhance the effect of the pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery.

Official Title
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Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?

Conditions
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Pediatric Patients Undergoing Hypospadias Surgery

Intervention / Treatment
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* Drug: normal saline
* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery American Society of Anesthesiologists (ASA) classification 1 2 Exclusion Criteria: patients who are having uncorrected heart deformity patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed patients with blood coagulopathy patients with diagnosed diabetes patients with diagnosed adrenal disease patients with fever above 37.5 degrees before surgery patients currently taking steroids patients contraindicated for dexamethasone administration

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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Male

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>normal saline is administrated to patients. | Drug: normal saline<br>* 2cc of normal saline is administered to patient instead of dexamethasone.<br>|
| Experimental: dexamethasone<br>0.5mg/kg dexamethasone is administered to patients. | Drug: dexamethasone<br>* dexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the duration from surgery to first PCA(patient-controlled analgesia) administration | the very first time of PCA usage after surgery, which is automatically recorded in PCA. | during 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of additional analgesia required for postoperative 48hrs. | the amount of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA. | during 48 hours after surgery | 
| the number of additional analgesia required for postoperative 48hrs. | the number of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA. | during 48 hours after surgery | 
| pain score for each time period | ask parents about their children's pain score at each time point | during 48 hours after surgery | 
| overall parents' satisfaction questionnaire | at 48 hours after surgery, parents are asked about satisfaction of their children's pain control | 48 hours after surgery |