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

Yonsei University

Status: Completed

Conditions: Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy

Treatments: Drug: Low dose dexamethasone; Drug: High dose dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04841018

4-2021-0047

Details and patient eligibility

About

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.

Enrollment: 273 patients

Sex: Male

Ages: 6 months to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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273 participants in 2 patient groups

Control

Experimental group

Description:

Higher dose of dexamethasone (0.5mg/kg) that is known to enhance the analgesic quality of caudal block from previous study

Treatment:

Drug: High dose dexamethasone

Dexamethasone

Experimental group

Description:

Lower, antiemetic dose of dexamethasone (0.15mg/kg)

Treatment:

Drug: Low dose dexamethasone