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

NCT02773602 | Unknown Phase 4

• 1 other identifier: HSC-MS-11-0002
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Keywords

Analgesia; caudal analgesia; ropivacaine; clonidine; dexamethasone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  Within 24 hours after surgery

Study Arms (3)

Dexamethasone

EXPERIMENTAL

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

Clonidine

ACTIVE COMPARATOR

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

Normal Saline

PLACEBO COMPARATOR

The patient only will receive Ropivacaine

Drug: Normal Saline

Interventions

Dexamethasone DRUG

200 μgm/kg of dexamethasone in 1 ml saline

Dexamethasone

Clonidine DRUG

2 μg/kg of clonidine in 1 ml saline

Clonidine

Normal Saline DRUG

1 ml of saline added to the ropivacaine, 0.2%, 1 ml/kg

Normal Saline

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The subject will receive presurgical caudal block
• American Society of Anesthesiologists (ASA) 1 or 2
• Day surgery unit
• weight 30 kg or less

You may not qualify if:

• Neuromuscular disease
• Back problem
• Caudal area skin infection
• Mental retardation
• Developmental delay
• Bleeding disorder

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Dexamethasone; Clonidine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Samia N Khalil, (M.B; B.CH)

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emad m. Sorial, (M.B; B.CH).

CONTACT

+1-713-500-6186; emad.m.sorial@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of pediatric Anesthesia

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: May 16, 2016
• Study Start: May 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

US (1)