Effect of Adding Different Concentrations of Dexmedetomidine to Bupivacaine in Caudal Block for Pediatrics

NCT06668220 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: caudal block for pediatrics
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pain is one of the medical problems frequently misdiagnosed, undertreated, and poorly under-stood, particularly in children.Poor pain management during childhood may have long-term deleterious impacts, including damaging neuro-endocrine reactions, disturbed eating and sleeping pat-terns, and increased pain sensitivity during subsequent painful events. A caudal epidural block is a common regional analgesic technique in pediatric surgery . It is a time-tested, safe, and efficacious technique However, the duration of post-operative pain seen with much pediatric surgery (\>24 h) outlasts the duration of analgesia afforded by a standard 'local-anesthetics only' caudal block (4-12 h) While continuous catheters prolong analgesic duration, such techniques are more cumbersome, require significant technical expertise and may be associated with higher adverse events. Contrary to this, adding adjuvants to local anesthetic is an appealing alternative. Adjuvants can improve the block and analgesic duration , reduce general anesthetic or local anesthetic requirements, allow for smoother emergence, lower incidence of emergence delirium, and facilitate early discharge in ambulatory surgery. Various adjuvants have been shown to enhance caudal blocks with varying degrees of success. A multitude of clinical trials and meta-analyses have analyzed the efficacy of different adjuvants such as alpha-2 agonists (clonidine and dexmedetomidine ), N-methyl-D-aspartate (NMDA) antagonists (ketamine and magnesium ), opioids (fentanyl, morphine, and tramadol ), corticosteroids (dexamethasone ), and acetylcholine esterase inhibitors (neostigmine). Dexmedetomidine has become more popular as a caudal adjuvant in children; it is a highly selective α2 agonist with sedative and analgesic properties. Dexmedetomidine possesses anxiolytic, sedative, sympatholytic, and analgesic properties without respiratory depressant effects In addition; dexmedetomidine has the ability to reduce both the anesthetic and opioid analgesic requirements during the perioperative period.

Conditions

Caudal Block for Postoperative Analgesia

Keywords

caudal block

Outcome Measures

Primary Outcomes (1)

• The duration of analgesia

  baseline and 24 hours

Secondary Outcomes (2)

• Total analgesic consumption

  baseline and 24 hours

• any neurological adverse effects

  baseline and 24 hours

Study Arms (2)

Group A: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 0.

ACTIVE COMPARATOR

Drug: Dexmedetomidine; Drug: Bupivacain

Group B: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 1

ACTIVE COMPARATOR

Drug: Dexmedetomidine; Drug: Bupivacain

Interventions

Dexmedetomidine DRUG

Dexmedetomidine has become more popular as a caudal adjuvant in children; it is a highly selective α2 agonist with sedative and analgesic properties. Dexmedetomidine possesses anxiolytic, sedative, sympatholytic, and analgesic properties without respiratory depressant effects In addition; dexmedetomidine has the ability to reduce both the anesthetic and opioid analgesic requirements during the perioperative period.

Group A: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 0.; Group B: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 1

Bupivacain DRUG

Bupivacaine is a potent local anesthetic with unique characteristics from the amide group of local anesthetics.

Group A: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 0.; Group B: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 1

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA I and II,
• aged 1-6 years
• scheduled for elective inguinal hernia repair

You may not qualify if:

• Guardians refusal
• Contraindication to caudal block like :
• Patients with congenital anomalies at the lower spine or meninges
• Patients with increased intracranial pressure
• Patients with skin infection at the site of injection
• Patients with bleeding diathesis
• Know allergy to any drug used in this study
• Patients with cardiopulmonary disease
• Patients with other congenital anomalies
• Patients with developmental delay

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• Xu D, Xiu M, Zhang X, Zhu P, Tian L, Feng J, Wu Y, Zhao Z, Luan H. Effect of dexmedetomidine added to ropivicaine for caudal anesthesia in patients undergoing hemorrhoidectomy: A prospective randomized controlled trial. Medicine (Baltimore). 2018 Aug;97(34):e11731. doi: 10.1097/MD.0000000000011731.

  PMID: 30142760 BACKGROUND

• Goyal V, Kubre J, Radhakrishnan K. Dexmedetomidine as an adjuvant to bupivacaine in caudal analgesia in children. Anesth Essays Res. 2016 May-Aug;10(2):227-32. doi: 10.4103/0259-1162.174468.

  PMID: 27212752 BACKGROUND

• Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52. doi: 10.1007/BF03021622.

  PMID: 16803911 BACKGROUND

• Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.

  PMID: 10702460 BACKGROUND

• Shah UJ, Nguyen D, Karuppiaah N, Martin J, Sehmbi H. Efficacy and safety of caudal dexmedetomidine in pediatric infra-umbilical surgery: a meta-analysis and trial-sequential analysis of randomized controlled trials. Reg Anesth Pain Med. 2021 May;46(5):422-432. doi: 10.1136/rapm-2020-102024. Epub 2021 Jan 15.

  PMID: 33452203 BACKGROUND

• She YJ, Zhang ZY, Song XR. Caudal dexmedetomidine decreases the required concentration of levobupivacaine for caudal block in pediatric patients: a randomized trial. Paediatr Anaesth. 2013 Dec;23(12):1205-12. doi: 10.1111/pan.12278. Epub 2013 Oct 12.

  PMID: 24383602 BACKGROUND

• Kim NY, Kim SY, Yoon HJ, Kil HK. Effect of dexmedetomidine on sevoflurane requirements and emergence agitation in children undergoing ambulatory surgery. Yonsei Med J. 2014 Jan;55(1):209-15. doi: 10.3349/ymj.2014.55.1.209.

  PMID: 24339309 BACKGROUND

• Polaner DM, Taenzer AH, Walker BJ, Bosenberg A, Krane EJ, Suresh S, Wolf C, Martin LD. Pediatric Regional Anesthesia Network (PRAN): a multi-institutional study of the use and incidence of complications of pediatric regional anesthesia. Anesth Analg. 2012 Dec;115(6):1353-64. doi: 10.1213/ANE.0b013e31825d9f4b. Epub 2012 Jun 13.

  PMID: 22696610 BACKGROUND

• Kil HK. Caudal and epidural blocks in infants and small children: historical perspective and ultrasound-guided approaches. Korean J Anesthesiol. 2018 Dec;71(6):430-439. doi: 10.4097/kja.d.18.00109. Epub 2018 Aug 8.

  PMID: 30086609 BACKGROUND

• Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702.

  PMID: 29319604 BACKGROUND

• Ecoffey C, Lacroix F, Giaufre E, Orliaguet G, Courreges P; Association des Anesthesistes Reanimateurs Pediatriques d'Expression Francaise (ADARPEF). Epidemiology and morbidity of regional anesthesia in children: a follow-up one-year prospective survey of the French-Language Society of Paediatric Anaesthesiologists (ADARPEF). Paediatr Anaesth. 2010 Dec;20(12):1061-9. doi: 10.1111/j.1460-9592.2010.03448.x.

  PMID: 21199114 BACKGROUND

• Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-156. doi: 10.1213/ANE.0000000000000446.

  PMID: 25393589 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

ahmed gamal mahmoud

CONTACT

+201129915169; ahmed.15235520@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: Model Description

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 31, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: November 13, 2024

Record last verified: 2024-11