Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?

Not Applicable

Completed

• Conditions: Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy
• Interventions: Drug: High dose dexamethasone; Drug: Low dose dexamethasone

• Registration Number: NCT04841018
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-24
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-12
• Primary Completion: 2023-08-29
• Status Verified: 2023-09
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 273

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	High dose dexamethasone	Higher dose of dexamethasone (0.5mg/kg) that is known to enhance the analgesic quality of caudal block from previous study
Dexamethasone	Low dose dexamethasone	Lower, antiemetic dose of dexamethasone (0.15mg/kg)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of