AdenotonsillectomyPhase 4e-PONB ENTNCT01096797
Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children
A Phase 4 study testing Sevoflurane in people with Adenotonsillectomy and Postoperative Pain, run by San Gerardo Hospital at 1 site in Italy.
Trial summary
The purpose of this study is to determine the incidence of pain, emergence delirium and the combination of those postoperative negative behaviours during the first 15 minutes after awakening from sevoflurane anesthesia in pre-school children. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Adenotonsillectomy, Postoperative Pain, Emergence Delirium
- What is being tested?
- Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2009to Mar 2010
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and Female children from 2 to 6 years of age
- American Society of Anaesthesiologists Classification (ASA) I: without systemic disease
- American Society of Anaesthesiologists Classification (ASA) II: moderate systemic disease
- Scheduled for elective tonsillectomy and/or adenoidectomy.
- Children whose parents (or legal tutors) have given their informed written consent
Who cannot join
- Emergency surgery.
- Children whose parents (or legal tutors) denied their own consensus
- Children with known cognitive impairment
- A story of kidney, liver, pulmonary or cardiac disease.
- A history of chronic pain or use of analgesic drugs.
- Familiar or personal history of malignant hyperthermia
- Need premedication or total intravenous anaesthesia.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Perioperative Medicine and Intensive Care. San Gerardo Hospital
Monza, MB, 20052
About this study
Official title: Prospective Cohort Study Evaluating Incidence and Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children
The purpose of this study is to determine the incidence of pain, emergence delirium and the combination of those postoperative negative behaviours during the first 15 minutes after awakening from sevoflurane anesthesia in pre-school children. Additionally this study will evaluate the relationship between emergence delirium and postoperative pain behaviour after adenotonsil surgery.
Read the detailed description
Tonsillectomy and/or adenoidectomy is the most common surgery performed in paediatric population. Sevoflurane is the most frequently volatile anaesthetic used in paediatric population. It is well tolerated, allows rapid anaesthesia induction, faster emergence, orientation. A child who emerges from sevoflurane anaesthesia may experience a variety of behavioural disturbances described as "emergence delirium" (ED).
ED has been described as "a mental disturbance during the recovery from general anaesthesia consisting of hallucinations, delusions and confusion manifested by moaning, restlessness, involuntary physical activity, and thrashing about in bed" in the immediate post anaesthesia period. Additionally paranoid ideation has been observed in combination with these emergence behaviours.
Restless recovery from anaesthesia is an important problem. It may lead, along with injury to the child, bleeding from surgical site, to accidental removal of IV catheters and drains. Once ED occur, extra nursing care may be necessary, as well as supplemental sedative and/or analgesic medications, which may be associated to respiratory depression or airway obstruction and may delay patient discharge. Although long-term psychological implications of ED remain unknown, children with restless recovery from anaesthesia are seven times more likely to have new-onset separation anxiety, apathy, eating and sleep problems.
ED after sevoflurane anaesthesia has been suggested both to be and not to be associated with postoperative pain behaviour. Accordingly, adequate pain relief has been found to reduce or have no effect on ED after sevoflurane anaesthesia. Because a self-evaluation is difficult In preschool boy observational scales based on behaviour like CHIPPS, FLACC or CHEOPS are used for the measurement of pain.
Given that the child's behaviour evaluation at emergence is made with observational scales, a superimposition between ED and pain measurement is possible. Nurses and doctors using behavioural scales for the evaluation of ED and pain may not be able to differentiate pain from ED during awakening. This may led to the treatment of an autolimitated disturb (ED) or to the under treatment of pain after surgery.
- Conditions
- Adenotonsillectomy, Postoperative Pain, Emergence Delirium
- Being tested
- Sevoflurane
- Medical subject headings
- Pain, Postoperative, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
- Anaesthesia induction: sevoflurane 4 to 6% by mask and IV propofol 2-6 mg/kg.
- Anaesthesia maintenance: sevoflurane 2-3 %
- Intraoperative and postoperative analgesia: IV fentanyl 1,5-2,5 mcg/kg, IV paracetamol 15 mg/kg
- Prevention of postoperative nausea and vomiting: dexamethasone 0,1 mg/kg, ondansetron 0,1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Children undergoing adenotonsillectomy | Experimental | Children between 2-6 years old undergoing elective adenoidectomy with or without tonsillectomy from the ENT Service of the San Gerardo Hospital. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence delirium evaluation: Pediatric Anesthesia Emergence Delirium scale (PAED)
Pediatric Anesthesia Emergence Delirium scale(PAED):The PAED scale consists of five psychometric items. To each of them it's possible to assign a score from 0 to 4 (maximum score 20 points). Emergence delirium was defined as a PAED scale score of 10 points of grater.
Measured: First 15 minutes after awakening.
Pain: Face, Legs, Activity, Cry, Consolability Scale (FLACCS); Children and Infants Postoperative Pain Scale (CHIPPS); Children Hospital of Eastern Ontario Pain Scale (CHEOPS)
- FLACCS: five behavioural items scale with a maximum score of 10 points. Significant pain behaviour correspond to a FLACCS score of 4 points or greater.
- CHIPPS: five behavioural items scale with a maximum score of 10 points. Significant pain behaviour correspond to a FLACCS score of 4 points or greater.
CHEOPS: five behavioural items scale with a maximum score of 13 points. Significant pain behaviour correspond to a CHEOPS score of 7 points or greater
Measured: 15 minutes after awakening
Secondary outcomes (3)
Age
Age groups: 2 to 4 ys and 5 to 6 ys
Time of exposure to sevoflurane
Awakening time
Time between end of sevoflurane exposure and extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AdenotonsillectomyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Gerardo Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca
- Investigators
- Pablo M Ingelmo, MD, Principal investigator, Department of anesthesiology and resuscitation I, San Gerardo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096797
- Sponsor's protocol ID
- AR-HSG 02-2009
- Acronym
- e-PONB ENT
- Status last verified
- Nov 2009
- First submitted
- 29 Mar 2010
- Last updated
- 31 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Holzki J, Kretz FJ. Changing aspects of sevoflurane in paediatric anaesthesia: 1975-99. Paediatr Anaesth. 1999;9(4):283-6. doi: 10.1046/j.1460-9592.1999.00415.x. No abstract available.
PubMed 10411761Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
PubMed 15114210Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007 Jan;104(1):84-91. doi: 10.1213/01.ane.0000250914.91881.a8.
PubMed 17179249Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.
PubMed 12760985Dahmani S, Stany I, Brasher C, Lejeune C, Bruneau B, Wood C, Nivoche Y, Constant I, Murat I. Pharmacological prevention of sevoflurane- and desflurane-related emergence agitation in children: a meta-analysis of published studies. Br J Anaesth. 2010 Feb;104(2):216-23. doi: 10.1093/bja/aep376. Epub 2010 Jan 3.
PubMed 20047899
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study Evaluating Incidence and Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children
- ClinicalTrials.gov ID
- NCT01096797
- Acronym / sponsor ID
- e-PONB ENT / AR-HSG 02-2009
- Conditions
- Adenotonsillectomy, Postoperative Pain, Emergence Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- San Gerardo HospitalUniversity, hospital or other
- Collaborators
- University of Milano Bicocca
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 31 Mar 2010 (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 the incidence of pain, emergence delirium and the combination of those postoperative negative behaviours during the first 15 minutes after awakening from sevoflurane anesthesia in pre-school children. Additionally this study will evaluate the relationship between emergence delirium and postoperative pain behaviour after adenotonsil surgery.
Detailed description
Tonsillectomy and/or adenoidectomy is the most common surgery performed in paediatric population. Sevoflurane is the most frequently volatile anaesthetic used in paediatric population. It is well tolerated, allows rapid anaesthesia induction, faster emergence, orientation. A child who emerges from sevoflurane anaesthesia may experience a variety of behavioural disturbances described as "emergence delirium" (ED).
ED has been described as "a mental disturbance during the recovery from general anaesthesia consisting of hallucinations, delusions and confusion manifested by moaning, restlessness, involuntary physical activity, and thrashing about in bed" in the immediate post anaesthesia period. Additionally paranoid ideation has been observed in combination with these emergence behaviours.
Restless recovery from anaesthesia is an important problem. It may lead, along with injury to the child, bleeding from surgical site, to accidental removal of IV catheters and drains. Once ED occur, extra nursing care may be necessary, as well as supplemental sedative and/or analgesic medications, which may be associated to respiratory depression or airway obstruction and may delay patient discharge. Although long-term psychological implications of ED remain unknown, children with restless recovery from anaesthesia are seven times more likely to have new-onset separation anxiety, apathy, eating and sleep problems.
ED after sevoflurane anaesthesia has been suggested both to be and not to be associated with postoperative pain behaviour. Accordingly, adequate pain relief has been found to reduce or have no effect on ED after sevoflurane anaesthesia. Because a self-evaluation is difficult In preschool boy observational scales based on behaviour like CHIPPS, FLACC or CHEOPS are used for the measurement of pain.
Given that the child's behaviour evaluation at emergence is made with observational scales, a superimposition between ED and pain measurement is possible. Nurses and doctors using behavioural scales for the evaluation of ED and pain may not be able to differentiate pain from ED during awakening. This may led to the treatment of an autolimitated disturb (ED) or to the under treatment of pain after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children undergoing adenotonsillectomy | Experimental | Drug: SevofluraneChildren between 2-6 years old undergoing elective adenoidectomy with or without tonsillectomy from the ENT Service of the San Gerardo Hospital. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male and Female children from 2 to 6 years of age
- American Society of Anaesthesiologists Classification (ASA) I: without systemic disease
- American Society of Anaesthesiologists Classification (ASA) II: moderate systemic disease
- Scheduled for elective tonsillectomy and/or adenoidectomy.
- Children whose parents (or legal tutors) have given their informed written consent
Key exclusion criteria (7 listed)
- Emergency surgery.
- Children whose parents (or legal tutors) denied their own consensus
- Children with known cognitive impairment
- A story of kidney, liver, pulmonary or cardiac disease.
- A history of chronic pain or use of analgesic drugs.
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 |
|---|---|---|
| Sevoflurane* Anaesthesia induction: sevoflurane 4 to 6% by mask and IV propofol 2-6 mg/kg. * Anaesthesia maintenance: sevoflurane 2-3 % * Intraoperative and postoperative analgesia: IV fentanyl 1,5-2,5 mcg/kg, IV paracetamol 15 mg/kg * Prevention of postoperative nausea and vomiting: dexamethasone 0,1 mg/kg, ondansetron 0,1 mg/kg | Drug | Children undergoing adenotonsillectomy |
Primary outcome
Emergence delirium evaluation: Pediatric Anesthesia Emergence Delirium scale (PAED)
Time frame: First 15 minutes after awakening.
Pediatric Anesthesia Emergence Delirium scale(PAED):The PAED scale consists of five psychometric items. To each of them it's possible to assign a score from 0 to 4 (maximum score 20 points). Emergence delirium was defined as a PAED scale score of 10 points of grater.
Pain: Face, Legs, Activity, Cry, Consolability Scale (FLACCS); Children and Infants Postoperative Pain Scale (CHIPPS); Children Hospital of Eastern Ontario Pain Scale (CHEOPS)
Time frame: 15 minutes after awakening
* FLACCS: five behavioural items scale with a maximum score of 10 points. Significant pain behaviour correspond to a FLACCS score of 4 points or greater. * CHIPPS: five behavioural items scale with a maximum score of 10 points. Significant pain behaviour correspond to a FLACCS score of 4 points or greater. CHEOPS: five behavioural items scale with a maximum score of 13 points. Significant pain behaviour correspond to a CHEOPS score of 7 points or greater
3 secondary outcomes
Age
Time of exposure to sevoflurane
Awakening time
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 31 Mar 2010.
- Background: PubMed 10411761Holzki J, Kretz FJ. Changing aspects of sevoflurane in paediatric anaesthesia: 1975-99. Paediatr Anaesth. 1999;9(4):283-6. doi: 10.1046/j.1460-9592.1999.00415.x. No abstract available.
- Results publication: PubMed 15114210Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
- Results publication: PubMed 17179249Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007 Jan;104(1):84-91. doi: 10.1213/01.ane.0000250914.91881.a8.
- Results publication: PubMed 12760985Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.
- Results publication: PubMed 20047899Dahmani S, Stany I, Brasher C, Lejeune C, Bruneau B, Wood C, Nivoche Y, Constant I, Murat I. Pharmacological prevention of sevoflurane- and desflurane-related emergence agitation in children: a meta-analysis of published studies. Br J Anaesth. 2010 Feb;104(2):216-23. doi: 10.1093/bja/aep376. Epub 2010 Jan 3.
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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.
Pablo M Ingelmo, MD principal investigator
Department of anesthesiology and resuscitation I, San Gerardo Hospital
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 Sevoflurane in people with Adenotonsillectomy and Postoperative Pain, run by San Gerardo Hospital at 1 site in Italy.
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 7 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 31 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 Italy. 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?
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?
Emergence delirium evaluation: Pediatric Anesthesia Emergence Delirium scale (PAED) (time frame: First 15 minutes after awakening.). The study lists 2 primary outcomes in all. 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 NCT01096797, which also lists 5 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 31 Mar 2010.