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Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery

T

Tehran University of Medical Sciences

Status and phase

Unknown
Phase 4

Conditions

Analgesia

Treatments

Drug: S(+)-ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT00532662
86-02-78-56790

Details and patient eligibility

About

Preemptive analgesia can improve postoperative pain management. Ketamine may prevent central sensitization during surgery and result in preemptive analgesia. The purpose of this study is to examine the effectiveness of ketamine as a preemptive analgesic as previous studies have shown the involvement of N-methyl-D-Aspartate (NMDA) receptor in neuroplasticity.

Full description

After receiving consent inform from parents, 40 children scheduled for orthopedic surgeries will be randomized to one of two groups: epidural group and intravenous group, both will receive 1 mg kg-1 S(+)-ketamine. All patients will receive caudal block anesthesia with marcaine. Cardiovascular monitoring will be assessed during operation. Follow up will continue for 24 hours after caudal block. Duration of analgesia, first time of analgesic request and complications will be recorded by an orthopedic assistant that is blinded to study. Data will be analyzed statistically by Chi square, t test and nonparametric tests.

Enrollment

40 estimated patients

Sex

All

Ages

Under 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children aged < = 12 years
  • Children scheduled for elective orthopedic surgery with caudal block
  • ASA score < = 3

Exclusion criteria

  • Contraindication for caudal block such as vertebral defect or infection at the site of block
  • Disagreement of parents
  • Patient's age > 12 years
  • ASA score > = 4

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

1
Experimental group
Description:
epidural s(+)-ketamine for supplementation of caudal anesthesia
Treatment:
Drug: S(+)-ketamine
2
Active Comparator group
Description:
intravenous ketamine for supplementation of caudal anesthesia
Treatment:
Drug: S(+)-ketamine

Trial contacts and locations

2

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Central trial contact

Hamid Reza Amiri, MD

Data sourced from clinicaltrials.gov

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