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

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

Tracking Information

• First Submitted Date: December 11, 2015
• First Posted Date: May 16, 2016
• Last Update Posted Date: May 16, 2016
• Study Start Date: May 2011
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 12, 2016)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 12, 2016)

• Number of children between the groups who received pain medication in the PACU [ Time Frame: Within 24 hours after surgery ]
• Number of children between the groups who received pain medication after hospital discharge [ Time Frame: Within 24 hours after surgery ]
• number of children group between the groups who required pain medication in first 24 h after surgery [ Time Frame: Within 24 hours after surgery ]
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dexamethasone or Clonidine as Adjuncts to Ropivacaine for Caudal Analgesia on Analgesia Duration in Children
• 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
• Brief Summary: Comparing the duration of pain relief from caudal analgesia when adjuncts like dexamethasone, clonidine, or saline (salt water) are added to ropivacaine.

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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Postoperative Pain

Intervention

• Drug: Dexamethasone
  200 μgm/kg of dexamethasone in 1 ml saline
• Drug: Clonidine
  2 μg/kg of clonidine in 1 ml saline
• Drug: Normal Saline
  1 ml of saline added to the ropivacaine, 0.2%, 1 ml/kg

Study Arms

• 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
  Intervention: Drug: Dexamethasone
• 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.

  Intervention: Drug: Clonidine
• Placebo Comparator: Normal Saline
  The patient only will receive Ropivacaine
  Intervention: Drug: Normal Saline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 12, 2016): 155
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2017
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 6 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02773602
• Other Study ID Numbers: HSC-MS-11-0002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Samia Khalil, The University of Texas Health Science Center, Houston
• Study Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Not Provided

Investigators

• Principal Investigator: Samia N Khalil, (M.B; B.CH); The University of Texas Health Science Center, Houston

• PRS Account: The University of Texas Health Science Center, Houston
• Verification Date: May 2016