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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Unknown status

CT.gov ID

NCT02773602

Collaborator

(none)

155

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Dexamethasone Drug: Clonidine Drug: Normal Saline	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

155 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Dexamethasone

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

Outcome Measures

Primary Outcome Measures

Duration of block [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.

Secondary Outcome Measures

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]
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.