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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Clonidine
Normal Saline
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Analgesia, caudal analgesia, ropivacaine, clonidine, dexamethasone

Eligibility Criteria

6 Months - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Memorial Hermann HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Clonidine

Normal Saline

Arm Description

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

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.

The patient only will receive Ropivacaine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of children between the groups who received pain medication in the PACU
Number of children between the groups who received pain medication after hospital discharge
number of children group between the groups who required pain medication in first 24 h 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.

Full Information

First Posted
December 11, 2015
Last Updated
May 12, 2016
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02773602
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Analgesia, caudal analgesia, ropivacaine, clonidine, dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
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
Arm Title
Clonidine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
The patient only will receive Ropivacaine
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
200 μgm/kg of dexamethasone in 1 ml saline
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
2 μg/kg of clonidine in 1 ml saline
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
1 ml of saline added to the ropivacaine, 0.2%, 1 ml/kg
Primary Outcome Measure Information:
Title
Duration of block
Description
Duration of block is calculated from time of first pain medication minus time of caudal placement. Caudal placement occurs before pain medication is administered.
Time Frame
Within 24 hours after surgery
Secondary Outcome Measure Information:
Title
Number of children between the groups who received pain medication in the PACU
Time Frame
Within 24 hours after surgery
Title
Number of children between the groups who received pain medication after hospital discharge
Time Frame
Within 24 hours after surgery
Title
number of children group between the groups who required pain medication in first 24 h after surgery
Time Frame
Within 24 hours after surgery
Title
Awakening time
Description
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.
Time Frame
Within 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emad m. Sorial, (M.B; B.CH).
Phone
+1-713-500-6186
Email
emad.m.sorial@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samia N Khalil, (M.B; B.CH)
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EMAD M SORIAL, (M.B; B.CH)
Phone
713-550-6186
Email
EMAD.M.SORIAL@UTH.TMC.EDU
First Name & Middle Initial & Last Name & Degree
Samia N Khalil, (M.B; B.CH)

12. IPD Sharing Statement

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

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