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

NCT05922605 | Unknown Phase 4 DMC

• 1 other identifier: Caudal S-ketamine
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Analgesia; S-ketamine; Pediatrics; Caudal Block; Hypospadias

Outcome Measures

Primary Outcomes (1)

• duration of caudal analgesia

  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 Outcomes (3)

• morphine consumption

  48 hours after caudal block

• FLACC score

  48 hours after the caudal block

• complication

  48 hours after the caudal block

Study Arms (2)

Group E

EXPERIMENTAL

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

Group C

ACTIVE COMPARATOR

The children are given 0.2%ropivacaine 0.7 ml／kg and saline of equal volume caudally.

Drug: Ropivacaine

Interventions

S-ketamine & Ropivacaine DRUG

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.

Group E

Ropivacaine DRUG

The experiment group (Group C) will receive ropivacaine 0.2% 0.7 ml／kg plain and equial volume saline caudally for postoperative analgesia.

Group C

Eligibility Criteria

• Age: 3 Months - 18 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tao Zhang: lead

Study Sites (1)

First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 15200652 BACKGROUND

• 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.

  PMID: 11696143 BACKGROUND

• 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.

  PMID: 12641687 BACKGROUND

• 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.

  PMID: 14742331 BACKGROUND

• 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.

  PMID: 11020749 BACKGROUND

• Brenner L, Marhofer P, Kettner SC, Willschke H, Machata AM, Al-Zoraigi U, Lundblad M, Lonnqvist PA. Ultrasound assessment of cranial spread during caudal blockade in children: the effect of different volumes of local anaesthetics. Br J Anaesth. 2011 Aug;107(2):229-35. doi: 10.1093/bja/aer128. Epub 2011 Jun 3.

  PMID: 21642642 BACKGROUND

• Narasimhan P, Kashyap L, Mohan VK, Arora MK, Shende D, Srinivas M, Kashyap S, Nath S, Khanna P. Comparison of caudal epidural block with paravertebral block for renal surgeries in pediatric patients: A prospective randomised, blinded clinical trial. J Clin Anesth. 2019 Feb;52:105-110. doi: 10.1016/j.jclinane.2018.09.007. Epub 2018 Sep 19.

  PMID: 30243061 BACKGROUND

MeSH Terms

Conditions

Hypospadias

Interventions

Esketamine; Ropivacaine

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Tao Zhang, M.D.

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

tao Zhang, MD

CONTACT

8613580482938; zhtao98@aliyun.com

weiyi Xu, B.M

CONTACT

8619875691896; xuweiyi75@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 28, 2023
• Study Start: June 20, 2023
• Primary Completion: April 30, 2025
• Study Completion: May 1, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)