Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

NCT01701778 | Completed Phase 2 DMC

• 2 other identifiers: FujianPHFujianPH-TRC-121002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower abdominal surgeries.

Conditions

Inguinal Hernia; Cryptorchidism

Keywords

Dexmedetomidine; Postoperative pain reaction; anesthesia; children

Outcome Measures

Primary Outcomes (1)

• Time to first rescue medication

  the Children and Infants Postoperative Pain Scale (CHIPPS)

  From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h

Secondary Outcomes (6)

• the number of patients not requiring rescue analgesia

  After surgery,up to 24h

• the sedation score

  After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h

• Residual motor block

  After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h

• the incidence of emergence agitation

  Participants will be followed for the duration of PACU stay, an expected average of 2 hours

• side effects

  From the administration of the caudal block until the end of study period, assessed up to postoperative 24h

Study Arms (3)

Caudal Dexmedetomidine

EXPERIMENTAL

Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane

Drug: Caudal Dexmedetomidine; Drug: sevoflurane

Intravenous Dexmedetomidine

EXPERIMENTAL

Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane

Drug: Intravenous Dexmedetomidine; Drug: sevoflurane

Placebo

PLACEBO COMPARATOR

Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane

Drug: Placebo; Drug: sevoflurane

Interventions

Caudal Dexmedetomidine DRUG

Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline

Also known as: Precedex

Caudal Dexmedetomidine

Intravenous Dexmedetomidine DRUG

Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg

Also known as: Precedex

Intravenous Dexmedetomidine

Placebo DRUG

Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline

Also known as: Levobupivacaine

Placebo

sevoflurane DRUG

Induction and maintain anaesthesia

Caudal Dexmedetomidine; Intravenous Dexmedetomidine; Placebo

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA status I-II
• aged 2-5 yr
• Undergoing unilateral orchiopexy/inguinal hernia repair

You may not qualify if:

• Hypersensitivity to any local anesthetics
• Patient has history of allergy, intolerance, or reaction to dexmedetomidine
• Infections at puncture sites
• Bleeding diathesis
• Preexisting neurological disease
• Diabetes mellitus
• Children with uncorrected cardiac lesions
• Children with heart block or liver impairment

Sponsors & Collaborators

• Yao Yusheng: lead
• West China Hospital: collaborator

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

Related Publications (1)

• Yao Y, Yu C, Zhang X, Guo Y, Zheng X. Caudal and intravenous dexmedetomidine similarly prolong the duration of caudal analgesia in children: A randomized controlled trial. Paediatr Anaesth. 2018 Oct;28(10):888-896. doi: 10.1111/pan.13469.

  PMID: 30302881 DERIVED

Related Links

• Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics

MeSH Terms

Conditions

Hernia, Inguinal; Cryptorchidism

Interventions

Dexmedetomidine; Levobupivacaine; Sevoflurane

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Yusheng Yao, M.D.

  Fujian Provincial Hospital

  PRINCIPAL INVESTIGATOR

• Yanqing Chen, M.D.

  Fujian Provicial Hospital

  PRINCIPAL INVESTIGATOR

• Jin Liu, M.D.

  West China Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Double-blind randomized controlled trial of caudal versus intravenous dexmedetomidine for supplementation of caudal analgesia in children

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 5, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

CN (1)