Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05979558 |
| Other study ID # |
NamsNepal |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 16, 2020 |
| Est. completion date |
December 10, 2021 |
Study information
| Verified date |
July 2023 |
| Source |
National Academy of Medical Sciences, Nepal |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to evaluate the postoperative analgesic effects of caudal
Ropivacaine with or without Dexmedetomidine in pediatric infraumbilical surgery. The main
question[s] it aims to answer are:
• if Caudal Dexmedetomidine with Ropivacaine would prolong the duration of analgesia in
children undergoing infraumbilical surgery.
Participants will receive ropivacaine with dexmedetomidine in infraumbilical surgery.
If there is a comparison group: Investigators will compare this with ropivacaine with a
placebo to see if the duration of analgesia differs.
Description:
Children have significant pain following surgery. It has been under-managed most of the time.
Poorly controlled post-operative pain increases the morbidity. It leads to post-operative
agitation, urinary retention, nausea and vomiting, hypoxia, pulmonary edema, cardiovascular
and temperature instability. So, postoperative pain management is an essential and important
component of pediatric postoperative care. Adequate pain control after surgery permits early
mobilization, reduces postoperative complication, prevents development of fear and anxiety
and allows early hospital discharge.
Caudal block is one of the modality of multimodal analgesia. It is a well-established,
effective and relatively safe technique used for intra and post-operative analgesia in
children undergoing abdominal and lower limb surgery. It provides excellent analgesia,
reduces intra-operative anesthetics drug requirements, ensures pain free recovery from
anesthesia, decreases stress response and avoids deleterious adverse effects of narcotic
drugs.
However, the main disadvantage of caudal block is being its short duration of action with
sole local anesthetics. Even long-acting local anesthetic drugs such as bupivacaine provides
only 4-8 hours of analgesia. The insertion of catheter in caudal space to administer repeated
doses or continuous infusions of local anesthetic drug is not popular because of concerns of
infection. So, various adjuvants like Fentanyl, Morphine, Ketamine, clonidine,
Dexmeditomidine etc. have been used to prolong the duration of analgesia.
Morphine and Fentanyl are opioids that have been used traditionally in combination with a
local anesthetic to achieve prolonged anesthetic effect. The addition of opioid does provide
better analgesia but there is a possibility of an increased incidence of pruritus, urinary
retention, nausea, vomiting and respiratory depression. Similarly, Ketamine and Clonidine are
the widely preferred adjuvant to caudal block but have their own number of unpleasant adverse
effects8.
Hence, there is still ongoing investigations to find for an adjuvant that can safely prolong
caudal analgesia. Recently, Dexmedetomidine has been used for this purpose. Various studies
have described the use of Dexmedetomidine with local anesthetic drugs in caudal block for the
management of postoperative pain in children. Saadawy et al. found that 1μg/kg caudal
dexmedetomidine with bupivacaine was associated with an extended duration of postoperative
analgesia while in other studies 2μg/kg Dexmedetomidine was used with caudal Bupivacaine or
Ropivacaine for providing postoperative analgesia in children undergoing lower abdominal and
perineal surgeries.
Dexmedetomidine is a highly specific and selective α2-adrenoceptor agonist that has been
described as a safe and effective additive in many anesthetic procedures. In contrast to
other agents, it has a sympatholytic, analgesic and sedative effects. It is remarkably free
from side effects except for hypotension and bradycardia. But studies investigating its
analgesic property in our population are limited.
Ropivacaine is a long-acting amino amide local anesthetic drug and was the first to be
formulated as a pure S-enantiomer. It is reported to have a better safety profile than
Bupivacaine with less risk for central nervous system and cardiac toxicity 10. It also
decreases unwanted motor block than Bupivacaine, which makes it a more suitable agent for
caudal epidural analgesia6.
Dexmedetomidine with Ropivacaine is commonly used to prolong the caudal analgesia in western
population but have not been well studied in our pediatric population. So investigators
designed this study to determine analgesic effect of caudal Dexmedetomidine with Ropivacaine
in pediatric infraumbilical surgeries.
HYPOTHESIS Caudal Dexmedetomidine with Ropivacaine would not prolong the duration of
analgesia in children undergoing infraumbilical surgery.
GENERAL OBJECTIVES To evaluate the postoperative analgesic effects of caudal Ropivacaine with
or without Dexmedetomidine in pediatric infraumbilical surgery SPECIFIC OBJECTIVES
1. To compare rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)in 24
hours of postoperative period.
2. To compare the time for first rescue analgesia.
3. To evaluate the total analgesics consumption in 24 hours of postoperative period.
4. To observe the side effects of study drugs (vomiting and bradycardia).
