Postoperative Pain
Conditions
Keywords
Analgesia, caudal analgesia, ropivacaine, clonidine, dexamethasone
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.
Interventions
DRUGDexamethasone
200 μgm/kg of dexamethasone in 1 ml saline
DRUGClonidine
2 μg/kg of clonidine in 1 ml saline
DRUGNormal Saline
1 ml of saline added to the ropivacaine, 0.2%, 1 ml/kg
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactEmad m. Sorial, (M.B; B.CH).
Outcome results
None listed