Postoperative PainPhase 1/2NCT00672347
Clonidine and Morphine in Caudal Anesthesia
A Phase 1/2 study testing Clonidine, Morphine and Bupivacaine plus clonidine and morphine in people with Postoperative Pain, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Clonidine, Morphine and Bupivacaine plus clonidine and morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Sep 2009
- Phase
- Phase 1/2
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Urogenital pediatric surgery
- Status physical(ASA) 1 and 2
Who cannot join
- Cutaneous infection in puncture site
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Casa de Belo Horizonte Hospital
Belo Horizonte, Minas Gerais
About this study
Official title: Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery
Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.
Read the detailed description
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort score scale, as well as the consumption of analgesics.
- Conditions
- Postoperative Pain
- Being tested
- Clonidine, Morphine, Bupivacaine plus clonidine and morphine, Bupivacaine
- Keywords
- caudal anesthesia, clonidine, morphine, bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
1 mcg/kg
MorphineDrug
20 mcg/kg
Bupivacaine plus clonidine and morphineDrug
bupivacaine 0,166% 1 ml/kg
clonidine 1 mcg/kg
morphine 20 mcg/kg
BupivacaineDrug
Caudal anesthesia with bupivacaine 0,166% 1 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| B | Active comparator | compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both Receives: Drug: Bupivacaine |
| C | Active comparator | compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine Receives: Drug: Clonidine |
| M | Active comparator | compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine Receives: Drug: Morphine |
| CM | Active comparator | compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine Receives: Drug: Bupivacaine plus clonidine and morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall postoperative consumption of analgesics.
Measured: 24 hours
Secondary outcomes (4)
The peroperative consumption of volatile anesthetics.
Measured: 3 hours
The peroperative Bispectral Index measure.
Measured: 3 hours
Postoperative Wong-Baker faces scale
Measured: 24 hours
Postoperative pain and discomfort score scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Casa de Misericórdia de Belo Horizonte
- Investigators
- Renato S Gomez, PhD, MD, Study director, Federal University of Minas GeraisMagda L Fernandes, M, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672347
- Sponsor's protocol ID
- 210665
- Status last verified
- Mar 2010
- First submitted
- 2 May 2008
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3. doi: 10.1097/01.ju.0000169138.90628.b9.
PubMed 16094063Luz G, Innerhofer P, Oswald E, Salner E, Hager J, Sparr H. Comparison of clonidine 1 microgram kg-1 with morphine 30 micrograms kg-1 for post-operative caudal analgesia in children. Eur J Anaesthesiol. 1999 Jan;16(1):42-6. doi: 10.1046/j.1365-2346.1999.00430.x.
PubMed 10084100Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. doi: 10.1213/01.ane.0000261521.52562.de.
PubMed 17513626
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery
- ClinicalTrials.gov ID
- NCT00672347
- Acronym / sponsor ID
- 210665
- Conditions
- Postoperative Pain
- Keywords
- caudal anesthesia, clonidine, morphine, bupivacaine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Santa Casa de Misericórdia de Belo Horizonte
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 May 2008 (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.
Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.
Detailed description
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort score scale, as well as the consumption of analgesics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| B | Active comparator | Drug: Bupivacainecompare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both |
| C | Active comparator | Drug: Clonidinecompare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine |
| M | Active comparator | Drug: Morphinecompare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine |
| CM | Active comparator | Drug: Bupivacaine plus clonidine and morphinecompares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Urogenital pediatric surgery
- Status physical(ASA) 1 and 2
Key exclusion criteria (1 listed)
- Cutaneous infection in puncture site
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 |
|---|---|---|
| Clonidine1 mcg/kg | Drug | C |
| Morphine20 mcg/kg | Drug | M |
| Bupivacaine plus clonidine and morphinebupivacaine 0,166% 1 ml/kg clonidine 1 mcg/kg morphine 20 mcg/kg | Drug | CM |
| BupivacaineCaudal anesthesia with bupivacaine 0,166% 1 ml/kg | Drug | B |
Primary outcome
The overall postoperative consumption of analgesics.
Time frame: 24 hours
4 secondary outcomes
The peroperative consumption of volatile anesthetics.
Time frame: 3 hours
The peroperative Bispectral Index measure.
Time frame: 3 hours
Postoperative Wong-Baker faces scale
Time frame: 24 hours
Postoperative pain and discomfort score scale
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2010.
- Background: PubMed 16094063Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3. doi: 10.1097/01.ju.0000169138.90628.b9.
- Background: PubMed 10084100Luz G, Innerhofer P, Oswald E, Salner E, Hager J, Sparr H. Comparison of clonidine 1 microgram kg-1 with morphine 30 micrograms kg-1 for post-operative caudal analgesia in children. Eur J Anaesthesiol. 1999 Jan;16(1):42-6. doi: 10.1046/j.1365-2346.1999.00430.x.
- Background: PubMed 17513626Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. doi: 10.1213/01.ane.0000261521.52562.de.
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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.
Renato S Gomez, PhD, MD study director
Federal University of Minas Gerais
Magda L Fernandes, M principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Clonidine, Morphine and Bupivacaine plus clonidine and morphine in people with Postoperative Pain, run by Federal University of Minas Gerais at 1 site in Brazil.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 19 Mar 2010. 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 Brazil. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall postoperative consumption of analgesics. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00672347, which also lists 3 linked publications.
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 19 Mar 2010.