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

The University of Texas System (UT)

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Clonidine; Drug: Dexamethasone; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02773602

HSC-MS-11-0002

Details and patient eligibility

About

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

Full 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.

Enrollment: 155 estimated patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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155 participants in 3 patient groups, including a placebo group

Dexamethasone

Experimental group

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

Treatment:

Drug: Dexamethasone

Clonidine

Active Comparator group

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.

Treatment:

Drug: Clonidine

Normal Saline

Placebo Comparator group

Description:

The patient only will receive Ropivacaine

Treatment:

Drug: Normal Saline