Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
During Intramuscular botulinum toxin injections for children with cerebral palsy, immobility is essential to inject botulinum toxin to the right muscle. Because children with cerebral palsy are generally unable to control their movement, deep sedation is required during this painful procedure.
Short-acting drugs such as propofol and remifentanil are widely used for pediatric anesthesia and sedation but still have possibility of over-sedation and associated complications due to their rather narrow therapeutic window. Therefore, objective scoring system to assess the level of sedation to provide an effective and safe sedation in children. Bispectral index (BIS) monitoring,an objective guidance of sedation might be helpful.
The present study is to investigate the validity of the BIS monitoring during deep sedation of children with cerebral palsy for injection of botulinum toxin.
Intramuscular botulinum toxin injections for children with cerebral palsy have been extensively performed to relive spasticity and improve rehabilitation. During procedure immobility is essential to inject botulinum toxin to the right muscle for optimal effect. Because children with cerebral palsy are generally unable to control their movement, deep sedation is required during this painful procedure.
Short-acting drugs with rapid, predictable onset and offset of action, such as propofol and remifentanil, facilitate infusion rate adjustments and rapid recovery. However, there is always the possibility of over-sedation, hypotension and respiratory depression due to their rather narrow therapeutic window.
Several clinical sedation scales have been used to provide an effective and safe sedation in children. Because clinical scoring depends on patient response to verbal or physical stimulation, it is difficult to assess the level of sedatin in patients with deep sedation during delicate phase of the procedure. Bispectral index (BIS) monitoring,an objective guidance of sedation might be helpful. Although BIS scores in children with conscious and deep sedation were reported to correlate with clinical sedation scales, the validity during painful procedure in children with cerebral palsy was not investigated yet.
The present study is to investigate the validity of the BIS monitoring and its correlation to University of Michigan sedation scale during deep sedation of children with cerebral palsy for injection of botulinum toxin.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores | Two independent investigators assessed the level of sedation using the Universtiy of Michigan sedation scale (UMSS) and modified observer's assessment of alertness and sedation (MOAAS) scales every 1 min during the induction of sedation and every 3 min during the maintenance of sedation. The BIS values at each UMSS and MOAAS score were collected. The correlation between the BIS score and UMSS score, and BIS score and MOAAS score was analyzed using the Spearman rank correlation test. The correlation coefficient is expressed as an r-value, and this value is expressed as a single value, not as a range with the lowest and highest values. The higher the value, the better the outcome. | From induction of sedation to completion of procedure(botulinum toxin injection) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
primary care clinic (rehabilitation)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Duk Hee Lee, M.D. | Yeungnam University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeungnam University Hospital | Daegu | 705-717 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12818940 | Background | McDermott NB, VanSickle T, Motas D, Friesen RH. Validation of the bispectral index monitor during conscious and deep sedation in children. Anesth Analg. 2003 Jul;97(1):39-43, table of contents. doi: 10.1213/01.ane.0000067402.02136.a2. | |
| 22871256 | Background | Soudant DL, Staal HM, Witlox AM, Vles JS. Conscious sedation or general anaesthetic for intramuscular botulinum toxin injections in children - a two centre cross-sectional prospective audit. Eur J Paediatr Neurol. 2013 Mar;17(2):219-20. doi: 10.1016/j.ejpn.2012.06.012. Epub 2012 Aug 4. No abstract available. |
Not provided
Not provided
no plan to share our data
Not provided
Not provided
Not provided
Not provided
This prospective observational study was approved by the Institutional Review Board (YUH-14-0319-O10) and was registered with ClinicalTrials.gov (NCT02096549) on March 28, 2014. Written informed consent from the participants' parents and, when appropriate, verbal assent from the participating children were obtained before enrollment in the study.
This study was conducted at Yeungnam Univerisity Hospital in South korea from March 2014 to April 2017. Twenty children with spastic CP, with an American Society of Anesthesiologists physical status of 1 and 2, aged between 3 and 18 years, who were scheduled for a botulinum toxin injection under deep sedation, were enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Children With Spastic Cerebral Palsy | children with spastic CP, with an American Society of Anesthesiologists physical status of 1 and 2, aged between 3 and 18 years, who were scheduled for a botulinum toxin injection under deep sedation, were enrolled. Children were excluded from the study if they had an anticipated difficult airway, unstable cardiac disease, craniofacial defect, allergy to drugs used in this study, and/or history of recent (< 8 weeks) pneumonia, bronchitis, asthma attack, or an upper respiratory infection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
22 children with cerebral palsy
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Spastic Cerebral Palsy | After confirmation of adequate spontaneous respiration 5 minutes after remifentanil infusion in children, an attending anesthesiologist administered propofol (1.5 mg/kg) mixed with lidocaine (1 mg/kg) over 1 minute followed by continuous infusion of propofol on the basis of clinical signs of arousability, movement, blood pressure, heart rate and respiratory rate. Two independent investigators, who were blinded to BIS values, assessed the level of sedation using the UMSS scores every minute from baseline to induction of deep sedation. BIS values measured immediately before stimulation for assessing the UMSS observation were collected by another independent investigator. The BIS value with a signal quality index (SQI) ≥ 50 was accepted for analysis. Spearman rank order correlation analysis was used to evaluate the relationship of BIS and UMSS. The cut-off BIS value for detecting deep sedation was determined by analysis of receiver-operating characteristic (ROC) curve. The area under the |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores | Two independent investigators assessed the level of sedation using the Universtiy of Michigan sedation scale (UMSS) and modified observer's assessment of alertness and sedation (MOAAS) scales every 1 min during the induction of sedation and every 3 min during the maintenance of sedation. The BIS values at each UMSS and MOAAS score were collected. The correlation between the BIS score and UMSS score, and BIS score and MOAAS score was analyzed using the Spearman rank correlation test. The correlation coefficient is expressed as an r-value, and this value is expressed as a single value, not as a range with the lowest and highest values. The higher the value, the better the outcome. | Children with spastic Cerebral Palsy undergoing botulinum toxin injection | Posted | Number | 97.5% Confidence Interval | correlation coefficient | From induction of sedation to completion of procedure(botulinum toxin injection) |
|
24 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Validity of Bispectral Index Monitoring | After confirmation of adequate spontaneous respiration 5 minutes after remifentanil infusion in children, an attending anesthesiologist administered propofol (1.5 mg/kg) mixed with lidocaine (1 mg/kg) over 1 minute followed by continuous infusion of propofol on the basis of clinical signs of arousability, movement, blood pressure, heart rate and respiratory rate. Two independent investigators, who were blinded to BIS values, assessed the level of sedation using the UMSS scores every minute from baseline to induction of deep sedation. BIS values measured immediately before stimulation for assessing the UMSS observation were collected by another independent investigator. The BIS value with a signal quality index (SQI) ≥ 50 was accepted for analysis. Spearman rank order correlation analysis was used to evaluate the relationship of BIS and UMSS. The cut-off BIS value for detecting deep sedation was determined by analysis of receiver-operating characteristic (ROC) curve. The area under the |
Not provided
Not provided
This study has some limitations. We couldn't identify the age-related correlations among the CP children undergoing botulinum toxin injection and we did not know the correlation with BIS scores and UMSS and MOAAS scores according to sex.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sung Mee Jung, M.D | Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Daegu, Republic of Korea | +82-53-620-3368 | applejsm@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2017 | Jun 15, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 18095958 | Background | American Academy of Pediatrics; American Academy of Pediatric Dentistry; Cote CJ, Wilson S; Work Group on Sedation. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update. Paediatr Anaesth. 2008 Jan;18(1):9-10. doi: 10.1111/j.1460-9592.2007.02404.x. No abstract available. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Children With Spastic Cerebral Palsy |
Children with spastic CP, with an American Society of Anesthesiologists physical status of 1 and 2, aged between 3 and 18 years, who were scheduled for a botulinum toxin injection under deep sedation, were enrolled. Children were excluded from the study if they had an anticipated difficult airway, unstable cardiac disease, craniofacial defect, allergy to drugs used in this study, and/or history of recent (< 8 weeks) pneumonia, bronchitis, asthma attack, or an upper respiratory infection. |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
Not provided
Not provided