NCT00532662

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 18, 2010

Status Verified

November 1, 2010

Enrollment Period

1.6 years

First QC Date

September 19, 2007

Last Update Submit

November 17, 2010

Conditions

Analgesia

Keywords

EpiduralIntravenousKetamineAnalgesiaCaudalPediatricRegionalLocal Anesthetics

Outcome Measures

Primary Outcomes (1)

  • pain score

    24 hours after anesthesia

Secondary Outcomes (1)

  • analgesic request

    24 hours after anesthesia

Study Arms (2)

1

EXPERIMENTAL

epidural s(+)-ketamine for supplementation of caudal anesthesia

Drug: S(+)-ketamine

2

ACTIVE COMPARATOR

intravenous ketamine for supplementation of caudal anesthesia

Drug: S(+)-ketamine

Interventions

S(+)-ketamineDRUG

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

12

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

orthopedic ward of Imam Khomeini hospital

Tehran, Tehran Province, 1419733141, Iran

RECRUITING

orthopedic surgery room- Imam Khomeini hospital

Tehran, Tehran Province, Iran

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Ramin Espandar, MD

    Imam Khomeini hospital- tehran university of medical sciences

    STUDY CHAIR

Central Study Contacts

Hamid Reza Amiri, MD

CONTACT

021-61192628hramiri@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 20, 2007

Study Start

November 1, 2007

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

November 18, 2010

Record last verified: 2010-11

Locations

IR(2)