Recruiting

Dexamethasone & Clonidine

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT02773602

Conditions

Postoperative Pain

Eligibility Criteria

Sex: All

Age: 0 - 6

Healthy Volunteers: Accepted

Interventions

Dexamethasone

Clonidine

Normal Saline

Study Details

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

Study ID

NCT02773602

Start date

May, 2011

Status verified date

May, 2016

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 6

Healthy Volunteers: Accepted

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 Design

Enrollment

155 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

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.

placebo comparator: Normal Saline

The patient only will receive Ropivacaine

Interventions

Dexamethasone

200 μgm/kg of dexamethasone in 1 ml saline

Clonidine

2 μg/kg of clonidine in 1 ml saline

Normal Saline

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

Primary outcome measure

  • Duration of block [ Time Frame: Within 24 hours after surgery ]

Central Contacts and Locations

Central contacts

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

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

Locations

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

EMAD M SORIAL, (M.B; B.CH)

713-550-6186EMAD.M.SORIAL@UTH.TMC.EDU

Principal Investigator:

Samia N Khalil, (M.B; B.CH)

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 16, 2016

Last verified

May, 2016

Keywords

  • Analgesia
  • caudal analgesia
  • ropivacaine
  • clonidine
  • dexamethasone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2016-05-16.