Is an Only ChildPhase 3NCT02181543
Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
A Phase 3 study testing Clonidine in people with Is an Only Child, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
Trial summary
The purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Is an Only Child
- What is being tested?
- Clonidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 3
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 2 - 12 Years.
- Need for tonsillectomy / adenotonsillectomy.
- Physical status of the American Society of Anesthesiologists (ASA) 1, 2 or 3.
- Anestesia geral com sevoflurano.
- Use of Intraoperative dipyrone, 30-50mg/Kg, IV.
Who cannot join
- Changes in consciousness.
- Neurological Deficit.
- Use of another drug as medication before anesthesia.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Recife, Pernambuco, 50.070-550
About this study
The purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane.
- Conditions
- Is an Only Child
- Being tested
- Clonidine
- Keywords
- Clonidine, Psychomotor agitation, Anesthesia recovery period, Tonsillectomy, Child, preschool
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose.
| Study group | Role | What they receive |
|---|---|---|
| Clonidine | Experimental | Clonidine 1μg/Kg, IV, single dose, anesthesia intraoperative. Receives: Drug: Clonidine |
| No Clonidine | No intervention | Usual care of Instituto de Medicina Integral Prof. Fernando Figueira. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative agitation
Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED).
Measured: 6 hours
Secondary outcomes (5)
Duration of postoperative agitation
Time in minutes.
Measured: 6 hours
Need for post-anesthetic drugs for treatment of agitation
Use of any drugs, such as sedatives, opioids, anti-inflammatory or anti-emetic for improvement agitation.
Measured: 6 hours
Any occurrence of post-anesthesia accidents: falls, bruises or disconnection of catheters
If any accident occurs in the recovery room, and postoperative (falls, bruises) disconnection of intravenous catheter or injuries.
Measured: 6 hours
Drowsiness
Clinical evaluation: patient awake, awake, alert or patient under hypnosis.
Measured: 6 hours
Parental satisfaction.
As parents answer the question if you are satisfied with the procedure performed, excluding other problems occurred in the hospital.
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 posted4 Jul 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Is an Only ChildStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Sandro Rolland de Souza, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- Alex SR Souza, PhD, Principal investigator, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)Fernando A Souza Júnior, MD, Study chair, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)Tania CM Couceiro, MD, Study chair, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)Ítalo GM Santos, Student, Study chair, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)Luciana C Lima, PhD, Study director, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181543
- Sponsor's protocol ID
- U1111-1157-8852
- Status last verified
- Oct 2017
- First submitted
- 2 Jul 2014
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hudek K. Emergence delirium: a nursing perspective. AORN J. 2009 Mar;89(3):509-16; quiz 517-9. doi: 10.1016/j.aorn.2008.12.026.
PubMed 19326585Silva LM, Braz LG, Modolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: 10.2223/JPED.1763.
PubMed 18372935Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page.
PubMed 11473855Malviya S, Voepel-Lewis T, Ramamurthi RJ, Burke C, Tait AR. Clonidine for the prevention of emergence agitation in young children: efficacy and recovery profile. Paediatr Anaesth. 2006 May;16(5):554-9. doi: 10.1111/j.1460-9592.2006.01818.x.
PubMed 16677266Fazi L, Jantzen EC, Rose JB, Kurth CD, Watcha MF. A comparison of oral clonidine and oral midazolam as preanesthetic medications in the pediatric tonsillectomy patient. Anesth Analg. 2001 Jan;92(1):56-61. doi: 10.1097/00000539-200101000-00011.
PubMed 11133600Tazeroualti N, De Groote F, De Hert S, De Ville A, Dierick A, Van der Linden P. Oral clonidine vs midazolam in the prevention of sevoflurane-induced agitation in children. a prospective, randomized, controlled trial. Br J Anaesth. 2007 May;98(5):667-71. doi: 10.1093/bja/aem071. Epub 2007 Apr 7.
PubMed 17416907Sousa-Junior FA, Souza ASR, Lima LC, Santos IGM, Menezes LAP, Ratis PAPL, Couceiro TCM. Intraoperative clonidine to prevent postoperative emergence delirium following sevoflurane anesthesia in pediatric patients: a randomized clinical trial. Braz J Anesthesiol. 2021 Jan-Feb;71(1):5-10. doi: 10.1016/j.bjane.2020.12.003. Epub 2020 Dec 25.
PubMed 33712253
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
- ClinicalTrials.gov ID
- NCT02181543
- Acronym / sponsor ID
- U1111-1157-8852
- Conditions
- Is an Only Child
- Keywords
- Clonidine, Psychomotor agitation, Anesthesia recovery period, Tonsillectomy, Child, preschool
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Jul 2014 (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 purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clonidine | Experimental | Drug: ClonidineClonidine 1μg/Kg, IV, single dose, anesthesia intraoperative. |
| No Clonidine | No intervention | –Usual care of Instituto de Medicina Integral Prof. Fernando Figueira. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 2 - 12 Years.
- Need for tonsillectomy / adenotonsillectomy.
- Physical status of the American Society of Anesthesiologists (ASA) 1, 2 or 3.
- Anestesia geral com sevoflurano.
- Use of Intraoperative dipyrone, 30-50mg/Kg, IV.
Key exclusion criteria (3 listed)
- Changes in consciousness.
- Neurological Deficit.
- Use of another drug as medication before anesthesia.
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 |
|---|---|---|
| Clonidine1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose. | Drug | Clonidine |
Primary outcome
Postoperative agitation
Time frame: 6 hours
Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED).
5 secondary outcomes
Duration of postoperative agitation
Time frame: 6 hours
Need for post-anesthetic drugs for treatment of agitation
Time frame: 6 hours
Any occurrence of post-anesthesia accidents: falls, bruises or disconnection of catheters
Time frame: 6 hours
Drowsiness
Time frame: 6 hours
Parental satisfaction.
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 4 Oct 2017.
- Background: PubMed 19326585Hudek K. Emergence delirium: a nursing perspective. AORN J. 2009 Mar;89(3):509-16; quiz 517-9. doi: 10.1016/j.aorn.2008.12.026.
- Background: PubMed 18372935Silva LM, Braz LG, Modolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: 10.2223/JPED.1763.
- Results publication: PubMed 11473855Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page.
- Results publication: PubMed 16677266Malviya S, Voepel-Lewis T, Ramamurthi RJ, Burke C, Tait AR. Clonidine for the prevention of emergence agitation in young children: efficacy and recovery profile. Paediatr Anaesth. 2006 May;16(5):554-9. doi: 10.1111/j.1460-9592.2006.01818.x.
- Results publication: PubMed 11133600Fazi L, Jantzen EC, Rose JB, Kurth CD, Watcha MF. A comparison of oral clonidine and oral midazolam as preanesthetic medications in the pediatric tonsillectomy patient. Anesth Analg. 2001 Jan;92(1):56-61. doi: 10.1097/00000539-200101000-00011.
- Results publication: PubMed 17416907Tazeroualti N, De Groote F, De Hert S, De Ville A, Dierick A, Van der Linden P. Oral clonidine vs midazolam in the prevention of sevoflurane-induced agitation in children. a prospective, randomized, controlled trial. Br J Anaesth. 2007 May;98(5):667-71. doi: 10.1093/bja/aem071. Epub 2007 Apr 7.
- Derived from this study: PubMed 33712253Sousa-Junior FA, Souza ASR, Lima LC, Santos IGM, Menezes LAP, Ratis PAPL, Couceiro TCM. Intraoperative clonidine to prevent postoperative emergence delirium following sevoflurane anesthesia in pediatric patients: a randomized clinical trial. Braz J Anesthesiol. 2021 Jan-Feb;71(1):5-10. doi: 10.1016/j.bjane.2020.12.003. Epub 2020 Dec 25.
- Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)Link provided by the sponsor.
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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.
Alex SR Souza, PhD principal investigator
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Fernando A Souza Júnior, MD study chair
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Tania CM Couceiro, MD study chair
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clonidine in people with Is an Only Child, run by Professor Fernando Figueira Integral Medicine Institute 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 5 inclusion and 3 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 4 Oct 2017. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Postoperative agitation (time frame: 6 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 NCT02181543, which also lists 7 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 4 Oct 2017.