Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias

October 26, 2023 updated by: Tao Zhang

Caudal analgesia with ropivacaine is commonly used in sub-umbilical pediatric surgery. However, increasing the dosage of ropivacaine has not been found to prolong the action significantly while complications will be serious.

Ketamine as an additive to caudal administration had been shown to prolong the duration of postoperative analgesia, while the analgesic effectiveness of S-ketamine, the S(+)-enantiomer of ketamine with less possibility to induce psychomotor disturbances, is not clear. In this prospective randomized double-blind clinical trial , the investigators aimed to study the effect of S-ketamine as additive on the duration of caudal analgesia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Forty-four children scheduled for hypospadias randomize into 2 groups. Group E (n=22) (0.2% ropivacaine 0.7 ml／kg and S-ketamine 0.5 mg/kg), group C(n=22)( 0.2%ropivacaine 0.7ml／kg and equivalent saline) intraoperative and postoperative hemodynamics will be recorded. Postoperative pain is assessed using an established 6-item FLACC score at 1h,3h,6h,12h,24h,48h, or the time when children complain of pain after surgery. A score of more15μg/kg is administered.Investigators propose to compare the duration of caudal analgesia provided by plain ropivacaine and by a mixture of ropivacaine and S-ketamine.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • First Affiliated Hospital, Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • informed parent consent, ASA I or II children, between 3months and 18 years of age,and weighing <28kg, scheduled for elective hypospadias surgery with general anesthesia will be recruited.

Exclusion Criteria:

  • Patients who have congenital abnormalities of lower spine and meninges.
  • Patients with hypersensitivity to any local anesthetics
  • Children with coagulation disorders
  • Presence of Infections at puncture sites
  • Preexisting neurological disease
  • Refusal to consent by parent/guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group E
the children are given a mixture of 0.2%ropivacaine 0.7 ml／kg and preservative-free S-ketamine 0.5 mg/kg for caudal analgesia.
Drug: S-ketamine & Ropivacaine
The experiment group (Group E) will receive a mixture of ropivacaine 0.2% 0.7 ml／kg and preservative-free S-ketamine 0.5 mg/kg caudally for postoperative analgesia.
Active Comparator: Group C
The children are given 0.2%ropivacaine 0.7 ml／kg and saline of equal volume caudally.
Drug: Ropivacaine
The experiment group (Group C) will receive ropivacaine 0.2% 0.7 ml／kg plain and equial volume saline caudally for postoperative analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of caudal analgesia
Time Frame: 48 hours after the caudal injection
Duration of analgesia is defined as the time from caudal injection to the first need for systemic analgesia.
48 hours after the caudal injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine consumption
Time Frame: 48 hours after caudal block
The Face, Legs, Activity, Cry, and Consolability (FLACC) scale at 1 hour (h), 3h,6h,12h,24h,48h or the time when children complain of pain after surgery. A score of more than 3 points is taken as an indication of inadequate analgesia and morphine 15ug/kg was administered .
48 hours after caudal block
FLACC score
Time Frame: 48 hours after the caudal block
The Face, Legs, Activity, Cry, and Consolability (FLACC) scale
48 hours after the caudal block
complication
Time Frame: 48 hours after the caudal block
the incidence of residual motor block, urinary retention, paraesthesia; the incidence of respiratory depression ,vomiting ,nystagmus ,pruritus，odd behavior;.the sedation scores etc.
48 hours after the caudal block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tao Zhang

Investigators

  • Study Chair: Tao Zhang, M.D., First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Caudal S-ketamine

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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