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

Effect of Dexamethasone or Clonidine When Given as Adjuncts to Ropivacaine for Caudal Analgesia on Duration of Analgesia Compared to Placebo in Children

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Dexamethasone; Drug: Clonidine; Drug: Normal Saline

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
• Enrollment (Anticipated): 155
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Emad m. Sorial, (M.B; B.CH).; Phone Number: +1-713-500-6186; Email: emad.m.sorial@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann Hospital
      • Contact: EMAD M SORIAL, (M.B; B.CH); Phone Number: 713-550-6186; Email: EMAD.M.SORIAL@UTH.TMC.EDU
      • Principal Investigator: Samia N Khalil, (M.B; B.CH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of children between the groups who received pain medication in the PACU		Within 24 hours after surgery
Number of children between the groups who received pain medication after hospital discharge		Within 24 hours after surgery
number of children group between the groups who required pain medication in first 24 h after surgery		Within 24 hours 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.	Within 24 hours after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (ESTIMATE): May 16, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): May 16, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Analgesia; ropivacaine; dexamethasone; clonidine; caudal analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympatholytics; Dexamethasone; Clonidine
• Other Study ID Numbers: HSC-MS-11-0002