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Completed

NCT Number: NCT04836962

Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?

Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. However, the caudal block is a neuraxial block that has a limitation in its duration with single shot and shows complications and adverse effects. In recent studies, the pudendal nerve block has been suggested as an alternative method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer duration compared to the caudal block, decreased the use of analgesics within 24 hours after surgery, and showed higher parental satisfaction. On the other hand, there have been many studies to prolong the duration of the relatively short duration of caudal block. Among them, dexamethasone administered intravenously is known to improve the duration of various regional blocks and reduce the administration of additional analgesics. The aim of this study is to verify whether a single administration of dexamethasone can enhance the effect of the pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery.

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Key information

Age range

6 month–3 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery
  • American Society of Anesthesiologists (ASA) classification 1~2

Exclusion criteria

  • patients who are having uncorrected heart deformity
  • patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed
  • patients with blood coagulopathy
  • patients with diagnosed diabetes
  • patients with diagnosed adrenal disease
  • patients with fever above 37.5 degrees before surgery
  • patients currently taking steroids
  • patients contraindicated for dexamethasone administration

Treatment and study plan

normal saline

Drug

2cc of normal saline is administered to patient instead of dexamethasone.

Dexamethasone

Drug

dexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc.

Primary outcomes

  1. the duration from surgery to first PCA(patient-controlled analgesia) administration

    Time frame: during 48 hours after surgery

    the very first time of PCA usage after surgery, which is automatically recorded in PCA.

Secondary outcomes

  1. the amount of additional analgesia required for postoperative 48hrs.

    Time frame: during 48 hours after surgery

    the amount of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA.

  2. the number of additional analgesia required for postoperative 48hrs.

    Time frame: during 48 hours after surgery

    the number of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA.

  3. pain score for each time period

    Time frame: during 48 hours after surgery

    ask parents about their children's pain score at each time point

  4. overall parents' satisfaction questionnaire

    Time frame: 48 hours after surgery

    at 48 hours after surgery, parents are asked about satisfaction of their children's pain control

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.