AnalgesiaPhase 4NCT00532662
Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery
A Phase 4 study testing S(+)-ketamine in people with Analgesia, run by Tehran University of Medical Sciences at 2 sites in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Analgesia
- What is being tested?
- S(+)-ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesIran
- Study dates
- Nov 2007to Jul 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged < = 12 years
- Children scheduled for elective orthopedic surgery with caudal block
- ASA score < = 3
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Iran2 sites, 2 recruiting
- Recruiting
orthopedic ward of Imam Khomeini hospital
Tehran, Tehran Province, 1419733141
Ramin Espandar, MD, 02161192627, espandarmd@sina.tums.ac.ir
- Recruiting
orthopedic surgery room- Imam Khomeini hospital
Tehran, Tehran Province
Siamak Yousef Sibdari, MD, 021-61192627, sibdari@gmail.com
About this study
Official title: Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-blind Controlled Clinical Trial.
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.
Read the 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.
- Conditions
- Analgesia
- Being tested
- S(+)-ketamine
- Keywords
- Epidural, Intravenous, Ketamine, Analgesia, Caudal, Pediatric, Regional, Local Anesthetics
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S(+)-ketamineDrug
epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | epidural s(+)-ketamine for supplementation of caudal anesthesia Receives: Drug: S(+)-ketamine |
| 2 | Active comparator | intravenous ketamine for supplementation of caudal anesthesia Receives: Drug: S(+)-ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Measured: 24 hours after anesthesia
Secondary outcomes (1)
analgesic request
Measured: 24 hours after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionJun 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Ramin Espandar, MD, Study chair, Imam Khomeini hospital- tehran university of medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532662
- Sponsor's protocol ID
- 86-02-78-56790
- Status last verified
- Nov 2010
- First submitted
- 19 Sep 2007
- Last updated
- 18 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-blind Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT00532662
- Acronym / sponsor ID
- 86-02-78-56790
- Conditions
- Analgesia
- Keywords
- Epidural, Intravenous, Ketamine, Analgesia, Caudal, Pediatric, Regional, Local Anesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 20 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: S(+)-ketamineepidural s(+)-ketamine for supplementation of caudal anesthesia |
| 2 | Active comparator | Drug: S(+)-ketamineintravenous ketamine for supplementation of caudal anesthesia |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged < = 12 years
- Children scheduled for elective orthopedic surgery with caudal block
- ASA score < = 3
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S(+)-ketamineepidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia | Drug | 1, 2 |
Primary outcome
pain score
Time frame: 24 hours after anesthesia
1 secondary outcome
analgesic request
Time frame: 24 hours after anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramin Espandar, MD study chair
Imam Khomeini hospital- tehran university of medical sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing S(+)-ketamine in people with Analgesia, run by Tehran University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamid Reza Amiri, MD (021-61192628, hramiri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: 24 hours after anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2010.