Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy
Conditions
Keywords
caudal block, low dose dexamethasone, postoperative pain
Brief summary
Caudal block is one of the most effective modalities to reduce pain both during and after the surgery involving areas under the umbilicus. According to previous research, 0.5mg/kg-1.5mg/kg dexamethasone is known to enhance the analgesic quality of caudal block in children. Despite the fact that this high dose of dexamethasone is used to treat airway edema in actual practice and no adverse side effect related to dosage has been reported, it is 3 to 15 times higher than the daily antiemetic dose of dexamethasone that is used in standard care of anesthesia. Therefore, our study aims to assess the effect of the more practical, antiemetic dose of dexamethasone (0.15mg/kg) as an adjuvant to enhance the quality of caudal block through a non-inferiority trial.
Interventions
After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.5mg/kg of intravenous dexamethasone
After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.15mg/kg of intravenous dexamethasone
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Patients enrolled are allocated into one of the following two groups: control group (group C) who receive a higher dose of dexamethasone known to enhance the effect of caudal block from previous study (0.5mg/kg) and dexamethasone group (group D) who receive a lower, antiemetic dose of dexamethasone (0.15mg/kg)
Eligibility
Sex/Gender
MALE
Age
6 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ages from 6 months old to 6 years old 2. Body weight Less than or equal to 16.7kg 3. American Society of Anesthesiologists (ASA) classification I or II 4. Patients receiving orchiopexy under general anesthesia
Exclusion criteria
1. Patients with uncorrected cardiac anomalies 2. Patients with vertebral anomalies 3. Diagnosis of diabetes mellitus 4. Diagnosis of adrenal disease 5. Currently on steroid 6. Body temperature above 37.5'C preoperatively 7. Allergy to dexamethasone 8. Laparoscopic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The need for additional analgesics during the first 48 hrs after surgery | Until 48 hours after the surgery | The child's parent is to be educated prior to the surgery so that when the pain score (FLACC or Wong-Baker Faces Scale) is 4 or above at home, he or she receives an additional acetaminophen. The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to assess the need for additional analgesics until 48 hours after the surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the first additional analgesic | Until 48 hours after the surgery | The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point. |
| total number of additional analgesic | Until 48 hours after the surgery | The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point. |
| pain score at each time point | Until 48 hours after the surgery | The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point. |
| scale of satisfaction at each time point | Until 48 hours after the surgery | The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point. |
Countries
South Korea
Outcome results
None listed