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

Pediatrics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05922605
• Other study ID #: Caudal S-ketamine
• Status: Recruiting
• Phase: Phase 4
• Start date: June 20, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: October 2023
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: tao Zhang, MD
• Phone: 8613580482938
• Email: zhtao98[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 1, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Tao Zhang

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	morphine consumption	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
Secondary	FLACC score	The Face, Legs, Activity, Cry, and Consolability (FLACC) scale	48 hours after the caudal block
Secondary	complication	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