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

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.

Study Overview

• Status: Completed
• Conditions: Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy
• Intervention / Treatment: Drug: High dose dexamethasone; Drug: Low dose dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeong-Rim Lee; Phone Number: 82-2-2228-2427; Email: MANYA@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health system, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; Higher dose of dexamethasone (0.5mg/kg) that is known to enhance the analgesic quality of caudal block from previous study	Drug: High dose dexamethasone; After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.5mg/kg of intravenous dexamethasone
Experimental: Dexamethasone; Lower, antiemetic dose of dexamethasone (0.15mg/kg)	Drug: Low dose dexamethasone; After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.15mg/kg of intravenous dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Jeong-Rim Lee, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): August 29, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: postoperative pain; caudal block; low dose dexamethasone
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Urogenital Abnormalities; Congenital Abnormalities; Testicular Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Cryptorchidism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 4-2021-0047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No