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

Primary Purpose

Postoperative Analgesia, S-ketamine, Pediatrics

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
S-ketamine & Ropivacaine
Ropivacaine
Sponsored by
Tao Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Analgesia

Eligibility Criteria

3 Months - 6 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria: informed parent consent, ASA I or II children, between 3months and 6 years of age, 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

Sites / Locations

  • First Affiliated Hospital, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group S

Group C

Arm Description

the children are given a mixture of 0.2%ropivacaine 1 ml/kg and preservative-free S-ketamine 0.5 mg/kg for caudal analgesia.

The children are given 0.2%ropivacaine 1 ml/kg and saline of equal volume caudally.

Outcomes

Primary Outcome Measures

duration of caudal analgesia
Duration of analgesia is defined as the time from caudal injection to the first need for systemic analgesia.

Secondary Outcome Measures

Paracetamol consumption
Postoperative Pain Measure (PPPM) at 1 hour (h), 3h,6h,12h,24h,48h or the time when children complain of pain after surgery. A score of more than 6 points is taken as an indication of inadequate analgesia and paracetamol 15 mg/kg was administered .
PPPM scores
Postoperative Pain Measure (PPPM)
complication
the incidence of residual motor block, urinary retention, paraesthesia; the incidence of respiratory depression ,vomiting ,nystagmus ,odd behavior;.the sedation scores etc.

Full Information

First Posted
June 15, 2023
Last Updated
June 27, 2023
Sponsor
Tao Zhang
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1. Study Identification

Unique Protocol Identification Number
NCT05922605
Brief Title
Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias
Official Title
Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2023 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tao Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Forty-four children scheduled for hypospadias randomize into 2 groups. Group S (n=22) (0.2% ropivacaine 1 ml/kg and S-ketamine 0.5 mg/kg), group C(n=22)( 0.2%ropivacaine 1ml/kg and equivalent saline) intraoperative and postoperative hemodynamics will be recorded. Postoperative pain is assessed using an established 15-item Parents' Postoperative Pain Measure (PPPM) at 1h,3h,6h,12h,24h,48h, or the time when children complain of pain after surgery. A score of more than 6 points is taken as an indication of inadequate analgesia and paracetamol 15 mg/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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Analgesia, S-ketamine, Pediatrics, Caudal Block, Hypospadias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The Patients allocated to study groups using computer generates random list & group assignment is sealed in sequentially numbered opaque envelopes that open after induction of anesthesia.
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group S
Arm Type
Experimental
Arm Description
the children are given a mixture of 0.2%ropivacaine 1 ml/kg and preservative-free S-ketamine 0.5 mg/kg for caudal analgesia.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
The children are given 0.2%ropivacaine 1 ml/kg and saline of equal volume caudally.
Intervention Type
Drug
Intervention Name(s)
S-ketamine & Ropivacaine
Intervention Description
The experiment group (Group S) will receive a mixture of ropivacaine 0.2% 1 ml/kg and preservative-free S-ketamine 0.5 mg/kg caudally for postoperative analgesia.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
The experiment group (Group C) will receive ropivacaine 0.2% 1 ml/kg plain and equial volume saline caudally for postoperative analgesia.
Primary Outcome Measure Information:
Title
duration of caudal analgesia
Description
Duration of analgesia is defined as the time from caudal injection to the first need for systemic analgesia.
Time Frame
48 hours after the caudal injection
Secondary Outcome Measure Information:
Title
Paracetamol consumption
Description
Postoperative Pain Measure (PPPM) at 1 hour (h), 3h,6h,12h,24h,48h or the time when children complain of pain after surgery. A score of more than 6 points is taken as an indication of inadequate analgesia and paracetamol 15 mg/kg was administered .
Time Frame
48 hours after caudal block
Title
PPPM scores
Description
Postoperative Pain Measure (PPPM)
Time Frame
48 hours after the caudal block
Title
complication
Description
the incidence of residual motor block, urinary retention, paraesthesia; the incidence of respiratory depression ,vomiting ,nystagmus ,odd behavior;.the sedation scores etc.
Time Frame
48 hours after the caudal block

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: informed parent consent, ASA I or II children, between 3months and 6 years of age, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tao Zhang, MD
Phone
8613580482938
Email
zhtao98@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
weiyi Xu, B.M
Phone
8619875691896
Email
xuweiyi75@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Zhang, M.D.
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xia Feng, MD
Phone
8613688877856
Email
fengxia@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15200652
Citation
Gunes Y, Secen M, Ozcengiz D, Gunduz M, Balcioglu O, Isik G. Comparison of caudal ropivacaine, ropivacaine plus ketamine and ropivacaine plus tramadol administration for postoperative analgesia in children. Paediatr Anaesth. 2004 Jul;14(7):557-63. doi: 10.1111/j.1460-9592.2004.01220.x.
Results Reference
background
PubMed Identifier
11696143
Citation
De Negri P, Ivani G, Visconti C, De Vivo P. How to prolong postoperative analgesia after caudal anaesthesia with ropivacaine in children: S-ketamine versus clonidine. Paediatr Anaesth. 2001 Nov;11(6):679-83. doi: 10.1046/j.1460-9592.2001.00742.x.
Results Reference
background
PubMed Identifier
12641687
Citation
Weber F, Wulf H. Caudal bupivacaine and s(+)-ketamine for postoperative analgesia in children. Paediatr Anaesth. 2003 Mar;13(3):244-8. doi: 10.1046/j.1460-9592.2003.01018.x.
Results Reference
background
PubMed Identifier
14742331
Citation
Martindale SJ, Dix P, Stoddart PA. Double-blind randomized controlled trial of caudal versus intravenous S(+)-ketamine for supplementation of caudal analgesia in children. Br J Anaesth. 2004 Mar;92(3):344-7. doi: 10.1093/bja/aeh076. Epub 2004 Jan 22.
Results Reference
background
PubMed Identifier
11020749
Citation
Koinig H, Marhofer P, Krenn CG, Klimscha W, Wildling E, Erlacher W, Nikolic A, Turnheim K, Semsroth M. Analgesic effects of caudal and intramuscular S(+)-ketamine in children. Anesthesiology. 2000 Oct;93(4):976-80. doi: 10.1097/00000542-200010000-00017.
Results Reference
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Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias

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