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

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ClinicalTrials.gov Identifier: NCT02773602
Recruitment Status : Unknown
Verified May 2016 by Samia Khalil, The University of Texas Health Science Center, Houston.
Recruitment status was:  Recruiting
First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Samia Khalil, The University of Texas Health Science Center, Houston

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Dexamethasone Drug: Clonidine Drug: Normal Saline Phase 4

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dexamethasone or Clonidine When Given as Adjuncts to Ropivacaine for Caudal Analgesia on Duration of Analgesia Compared to Placebo in Children
Study Start Date : May 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: Dexamethasone
200 μgm/kg of dexamethasone in 1 ml saline
Active Comparator: 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.

 Drug: Clonidine
2 μg/kg of clonidine in 1 ml saline
Placebo Comparator: Normal Saline
The patient only will receive Ropivacaine
 Drug: Normal Saline
1 ml of saline added to the ropivacaine, 0.2%, 1 ml/kg


Outcome Measures
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Primary Outcome Measures :
  1. Duration of block [ Time Frame: Within 24 hours after surgery ]
    Duration of block is calculated from time of first pain medication minus time of caudal placement. Caudal placement occurs before pain medication is administered.


Secondary Outcome Measures :
  1. Number of children between the groups who received pain medication in the PACU [ Time Frame: Within 24 hours after surgery ]
  2. Number of children between the groups who received pain medication after hospital discharge [ Time Frame: Within 24 hours after surgery ]
  3. number of children group between the groups who required pain medication in first 24 h after surgery [ Time Frame: Within 24 hours after surgery ]
  4. Awakening time [ Time Frame: Within 24 hours after surgery ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773602


Contacts
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Contact: Emad m. Sorial, (M.B; B.CH). +1-713-500-6186 emad.m.sorial@uth.tmc.edu

Locations
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United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: EMAD M SORIAL, (M.B; B.CH)    713-550-6186    EMAD.M.SORIAL@UTH.TMC.EDU   
Principal Investigator: Samia N Khalil, (M.B; B.CH)         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Samia N Khalil, (M.B; B.CH) The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Samia Khalil, Professor of pediatric Anesthesia, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02773602    
Other Study ID Numbers: HSC-MS-11-0002
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Keywords provided by Samia Khalil, The University of Texas Health Science Center, Houston:
Analgesia
caudal analgesia
ropivacaine
clonidine
dexamethasone
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dexamethasone
Clonidine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics
Sensory System Agents
Antihypertensive Agents
Sympatholytics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action