Dexamethasone or Clonidine as Adjuncts to Ropivacaine for Caudal Analgesia on Analgesia Duration in Children
NCT ID: NCT02773602
Last Updated: 2016-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
155 participants
INTERVENTIONAL
2011-05-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dexamethasone
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
Dexamethasone
200 μgm/kg of dexamethasone in 1 ml saline
Clonidine
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.
Clonidine
2 μg/kg of clonidine in 1 ml saline
Normal Saline
The patient only will receive Ropivacaine
Normal Saline
1 ml of saline added to the ropivacaine, 0.2%, 1 ml/kg
Interventions
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Dexamethasone
200 μgm/kg of dexamethasone in 1 ml saline
Clonidine
2 μg/kg of clonidine in 1 ml saline
Normal Saline
1 ml of saline added to the ropivacaine, 0.2%, 1 ml/kg
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) 1 or 2
* Day surgery unit
* weight 30 kg or less
Exclusion Criteria
* Back problem
* Caudal area skin infection
* Mental retardation
* Developmental delay
* Bleeding disorder
6 Months
6 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Samia Khalil
Professor of pediatric Anesthesia
Principal Investigators
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Samia N Khalil, (M.B; B.CH)
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Memorial Hermann Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-11-0002
Identifier Type: -
Identifier Source: org_study_id
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