Postoperative PainPhase 2clonidineNCT02769390
Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
A Phase 2 study testing Clonidine 1 mcg/Kg, Clonidine 2 mcg/ Kg and Clonidine 3 mcg/ Kg in people with Postoperative Pain, run by Federal University of Minas Gerais.
Trial summary
The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery… Read more about this study
- Who is it for?
- Ages 1 year to 10 years, men only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Clonidine 1 mcg/Kg, Clonidine 2 mcg/ Kg and Clonidine 3 mcg/ Kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Nov 2015
- Phase
- Phase 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
- Men only
- No healthy volunteers
- Child
Who may be able to join
- CHildren 1 - 10 years old.
- ASA I E II ( American Society of Anesthesiology)
- hypospadias surgery
Who cannot join
- parents refuse
- Infection
- Coagulation disorders
- Allergy to anesthetics
- Abnormalities of the sacral spine
About this study
The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable.
Read the detailed description
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity, cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable. Postoperative hemodynamics parameters will be recordes at 24 h.
- Conditions
- Postoperative Pain
- Being tested
- Clonidine 1 mcg/Kg, Clonidine 2 mcg/ Kg, Clonidine 3 mcg/ Kg
- Keywords
- Analgesia, Bupivacaine, Clonidine
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonidine 1 mcg/KgDrug
Also called Atensine
Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
Clonidine 2 mcg/ KgDrug
Also called Atensine
Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
Clonidine 3 mcg/ KgDrug
Also called Atensine
Clonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine 0,166% | No intervention | General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% for hypospadia surgery |
| Clonidine 1 mcg/Kg | Active comparator | IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery Receives: Drug: Clonidine 1 mcg/Kg |
| Clonidine 2 mcg/ Kg | Active comparator | IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery Receives: Drug: Clonidine 2 mcg/ Kg |
| Clonidine 3 mcg/Kg | Active comparator | General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery Receives: Drug: Clonidine 3 mcg/ Kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption
Measured: 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Santiago Gomez, Federal University of Minas Gerais
- Investigators
- ana claudia mota bonisson, M, Principal investigator, Hospital da Baleia - Fundação Benjamim Guimaraes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769390
- Sponsor's protocol ID
- CAAE23332313600005149
- Acronym
- clonidine
- Status last verified
- May 2016
- First submitted
- 9 Apr 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Fernandes ML, Pires KC, Tiburcio MA, Gomez RS. Caudal bupivacaine supplemented with morphine or clonidine, or supplemented with morphine plus clonidine in children undergoing infra-umbilical urological and genital procedures: a prospective, randomized and double-blind study. J Anesth. 2012 Apr;26(2):213-8. doi: 10.1007/s00540-011-1297-y. Epub 2011 Dec 10.
PubMed 22159880Mauch J, Weiss M. [Pediatric caudal anesthesia: importance and aspects of safety concerns]. Schmerz. 2012 Aug;26(4):443-53; quiz 454. doi: 10.1007/s00482-012-1202-0. German.
PubMed 22855315
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
- ClinicalTrials.gov ID
- NCT02769390
- Acronym / sponsor ID
- clonidine / CAAE23332313600005149
- Conditions
- Postoperative Pain
- Keywords
- Analgesia, Bupivacaine, Clonidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 May 2016 (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 use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable.
Detailed description
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity, cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable. Postoperative hemodynamics parameters will be recordes at 24 h.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 0,166% | No intervention | –General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% for hypospadia surgery |
| Clonidine 1 mcg/Kg | Active comparator | Drug: Clonidine 1 mcg/KgIGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery |
| Clonidine 2 mcg/ Kg | Active comparator | Drug: Clonidine 2 mcg/ KgIGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery |
| Clonidine 3 mcg/Kg | Active comparator | Drug: Clonidine 3 mcg/ KgGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- CHildren 1 - 10 years old.
- ASA I E II ( American Society of Anesthesiology)
- hypospadias surgery
Key exclusion criteria (5 listed)
- parents refuse
- Infection
- Coagulation disorders
- Allergy to anesthetics
- Abnormalities of the sacral spine
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 |
|---|---|---|
| Clonidine 1 mcg/KgAlso: AtensineClonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery | Drug | Clonidine 1 mcg/Kg |
| Clonidine 2 mcg/ KgAlso: AtensineClonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery | Drug | Clonidine 2 mcg/ Kg |
| Clonidine 3 mcg/ KgAlso: AtensineClonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery | Drug | Clonidine 3 mcg/Kg |
Primary outcome
Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption
Time frame: 24 hours after the surgery
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 13 May 2016.
- Background: PubMed 22159880Fernandes ML, Pires KC, Tiburcio MA, Gomez RS. Caudal bupivacaine supplemented with morphine or clonidine, or supplemented with morphine plus clonidine in children undergoing infra-umbilical urological and genital procedures: a prospective, randomized and double-blind study. J Anesth. 2012 Apr;26(2):213-8. doi: 10.1007/s00540-011-1297-y. Epub 2011 Dec 10.
- Background: PubMed 22855315Mauch J, Weiss M. [Pediatric caudal anesthesia: importance and aspects of safety concerns]. Schmerz. 2012 Aug;26(4):443-53; quiz 454. doi: 10.1007/s00482-012-1202-0. German.
- Individual participant dataSharing planned: Undecided
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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.
ana claudia mota bonisson, M principal investigator
Hospital da Baleia - Fundação Benjamim Guimaraes
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clonidine 1 mcg/Kg, Clonidine 2 mcg/ Kg and Clonidine 3 mcg/ Kg in people with Postoperative Pain, run by Federal University of Minas Gerais.
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: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption (time frame: 24 hours after the surgery). 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 NCT02769390, which also lists 2 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 13 May 2016.