Postoperative AnalgesiaPhase 4NCT00200564
Ketamine and Postoperative Analgesia in Children
A Phase 4 study testing ketamine in people with Postoperative Analgesia, run by Nantes University Hospital at 1 site in France.
Trial summary
The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6… Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- ketamine
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2004to not given
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 6 months to 6 years of age
- American Society of Anesthesiologists (ASA) I or II
- Undergoing elective surgery with intraoperative caudal analgesia
Who cannot join
- ASA III or IV
- Contraindication to caudal anesthesia
- Allergy to drugs used in the study
- Failure in caudal puncture
- Administration of morphine derivative
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, 44093
Véronique Bazin, MD, 00 33 2 40 08 35 47, veronique.bazin@chu-nantes.fr
About this study
The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). Caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.
- Conditions
- Postoperative Analgesia
- Being tested
- ketamine
- Keywords
- Pediatrics, ketamine, postoperative analgesia, nalbuphine, Postoperative analgesia in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of pain scores (CHEOPS) measured
Measured: every 2 hours during the first 24 hours after eyes open
Secondary outcomes (6)
Evaluation by the parents and nurses of the quality of analgesia with a visual analogue scale graded from 0 to 10
Measured: at the 24th hour
Number of painful episodes requiring additional boluses of nalbuphine
Number of children requiring morphine after inefficiency of additional boluses of nalbuphine
Percentage of children with side effects related to injection of ketamine
Time to complete feeding
Percentage of children with nausea or vomiting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Véronique Bazin, MD, Principal investigator, Nantes UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200564
- Sponsor's protocol ID
- BRD/03/12-H
- Status last verified
- Jul 2005
- First submitted
- 12 Sep 2005
- Last updated
- 23 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine and Postoperative Analgesia in Children
- ClinicalTrials.gov ID
- NCT00200564
- Acronym / sponsor ID
- BRD/03/12-H
- Conditions
- Postoperative Analgesia
- Keywords
- Pediatrics, ketamine, postoperative analgesia, nalbuphine, Postoperative analgesia in children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2004
- First posted
- 20 Sep 2005 (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.
The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). Caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 6 months to 6 years of age
- American Society of Anesthesiologists (ASA) I or II
- Undergoing elective surgery with intraoperative caudal analgesia
Key exclusion criteria (5 listed)
- ASA III or IV
- Contraindication to caudal anesthesia
- Allergy to drugs used in the study
- Failure in caudal puncture
- Administration of morphine derivative
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 |
|---|---|---|
| ketamine | Drug | – |
Primary outcome
Area under the curve of pain scores (CHEOPS) measured
Time frame: every 2 hours during the first 24 hours after eyes open
6 secondary outcomes
Evaluation by the parents and nurses of the quality of analgesia with a visual analogue scale graded from 0 to 10
Time frame: at the 24th hour
Number of painful episodes requiring additional boluses of nalbuphine
Number of children requiring morphine after inefficiency of additional boluses of nalbuphine
Percentage of children with side effects related to injection of ketamine
Time to complete feeding
Percentage of children with nausea or vomiting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2007.
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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.
Véronique Bazin, MD principal investigator
Nantes UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ketamine in people with Postoperative Analgesia, run by Nantes University Hospital at 1 site in France.
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 5 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 23 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Véronique Bazin, MD (00 33 2 40 08 35 47, veronique.bazin@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of pain scores (CHEOPS) measured (time frame: every 2 hours during the first 24 hours after eyes open). 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 23 Oct 2007.