Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy Clinical Trial
Official title:
Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?
| Verified date | September 2023 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 273 |
| Est. completion date | September 1, 2023 |
| Est. primary completion date | August 29, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 6 Months to 6 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Yonsei University Health System, Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The need for additional analgesics during the first 48 hrs after 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. | Until 48 hours after the surgery | |
| Secondary | Time to the first additional analgesic | 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. | Until 48 hours after the surgery | |
| Secondary | total number of additional analgesic | 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. | Until 48 hours after the surgery | |
| Secondary | pain score at each time point | 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. | Until 48 hours after the surgery | |
| Secondary | scale of satisfaction at each time point | 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. | Until 48 hours after the surgery |