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

Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-blind Controlled Clinical Trial.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00532662

Enrollment

Registered

2007-09-20

Start date

2007-11-30

Completion date

2009-07-31

Last updated

2010-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Keywords

Epidural, Intravenous, Ketamine, Analgesia, Caudal, Pediatric, Regional, Local Anesthetics

Brief summary

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.

Detailed 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.

Interventions

DRUGS(+)-ketamine

epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Years

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

Design outcomes

Primary

Measure	Time frame
pain score	24 hours after anesthesia

Secondary

Measure	Time frame
analgesic request	24 hours after anesthesia

Countries

Iran

Contacts

Primary ContactHamid Reza Amiri, MD

hramiri@gmail.com021-61192628

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026