Clinical trial NCT02773602: Dexamethasone or Clonidine as Adjuncts to Ropivacaine for Caudal Analgesia on Analgesia Duration in Children
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Analgesia
caudal analgesia
ropivacaine
clonidine
dexamethasone
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 155
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of block
timeFrame: Within 24 hours after surgery
Secondary outcomes:
measure: Number of children between the groups who received pain medication in the PACU
timeFrame: Within 24 hours after surgery
measure: Number of children between the groups who received pain medication after hospital discharge
timeFrame: Within 24 hours after surgery
measure: number of children group between the groups who required pain medication in first 24 h after surgery
timeFrame: Within 24 hours after surgery
measure: Awakening time
timeFrame: Within 24 hours after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Samia N Khalil, (M.B; B.CH)
role: PRINCIPAL_INVESTIGATOR
References: