Background: The purpose of this retrospective study was to examine the benefits, risks and costs ... more Background: The purpose of this retrospective study was to examine the benefits, risks and costs associated with aprotinin use in children who underwent repair of an atrial septal defect (ASD). The primary aim was to determine whether the transfusion rate is lower in children who received aprotinin compared with those who did not during ASD repair. The use of aprotinin has been shown to reduce transfusion requirements for children undergoing primary or secondary repair of congenital cardiac anomalies. However, past studies have not reported the benefits of this agent during low complexity procedures such as ASD repair. Methods: All children who underwent ASD repair over 6 years (3 years pre-and postroutine use of aprotinin for all CPB cases in the institution) were identified, and their medical records reviewed. Children with multiple congenital cardiac lesions were excluded. The following data were recorded: demographics and baseline laboratory findings, intraoperative use of aprotinin, cardiopulmonary bypass information including details of ultrafiltration, all intraoperative and postoperative transfusions, postoperative bleeding and relevant laboratory findings. Results: One hundred and fifteen children were included, 66 of whom received aprotinin. Transfusion rates were not different between children who received aprotinin [n = 8 (12%)] and those who did not [n = 3 (6%)]. Furthermore, changes in hematocrit were not different between groups. These findings were similar when children £15 kg were compared with those >15 kg. Conclusions: This study suggests that aprotinin use offers no benefit for children undergoing isolated repair of an ASD.
of hospital-wide monitoring standards, a quality assurance (QA) tool was prospectively completed ... more of hospital-wide monitoring standards, a quality assurance (QA) tool was prospectively completed for 1140 children (aged 2.96 ? 3.7 yr) sedated for procedures by nonanesthesiologists.
P Pu ur rp po os se e: : To determine if low-dose ketorolac would improve analgesia while minimiz... more P Pu ur rp po os se e: : To determine if low-dose ketorolac would improve analgesia while minimizing unwanted side effects in adolescents following posterior spinal fusion (PSF).
Background: Otherwise healthy children who present for elective surgery with an upper respiratory... more Background: Otherwise healthy children who present for elective surgery with an upper respiratory infection (URI) may be at risk for perioperative respiratory complications. This risk may be increased in children with congenital heart disease who undergo cardiac surgery while harboring a URI because of their compromised cardiopulmonary status. Therefore, this study was designed to determine the incidence of peri-and postoperative complications in children undergoing cardiac surgery while harboring a URI.
Participation of children in clinical research requires not only parental permission but also the... more Participation of children in clinical research requires not only parental permission but also the assent of the child. Although there is no fixed age at which assent should be sought, investigators should obtain assent from children considered able to provide it. This study was designed to determine children's understanding of the elements of disclosure for studies in which they had assented to participate. The study population included 102 children aged 7-18 yr who had given their assent to participate in a clinical anesthesia or surgical study. Children were interviewed using a semistructured format to determine their understanding of eight core elements of disclosure for the study to which they had agreed to participate. Two independent assessors scored the children's levels of understanding of these elements. The children's perceived level of understanding of the elements of disclosure was significantly greater than their measured understanding (7.0 +/- 2.4 vs 5.3 +/- 2.7, 0-10 scale; P< 0.0001). Complete understanding of the elements of disclosure for all children ranged from 30.4 to 89.4%. Children aged more than 11 yr had significantly greater understanding compared with younger children, particularly with respect to understanding of the study protocol, the benefits, and the freedom to withdraw. Children approached for their assent to participate in a clinical anesthesia or surgery study have limited understanding of the elements of disclosure and their role as a research participant, particularly if they are aged less than 11 yr.
... have been discussed. Alan R. Tait, Ph.D.*. Shobha Malviya, MD. Terri Voepel-Lewis, MSN, RN. .... more ... have been discussed. Alan R. Tait, Ph.D.*. Shobha Malviya, MD. Terri Voepel-Lewis, MSN, RN. ... assumptions correct? Katz, V; Balderston, K; DeFreest, M American Journal of Obstetrics and Gynecology, 192(6): 1916-1920. 10.1016 ...
Self-reported pain scores are used widely in clinical and research settings, yet little is known ... more Self-reported pain scores are used widely in clinical and research settings, yet little is known about their interpretability in children. In this prospective, observational study we evaluated the relationship between 0 to 10 numerical rating scale (NRS) pain scores and other self-reported, clinically meaningful outcomes, including perceived need for medicine (PNM), pain relief (PR), and perceived satisfaction (PS) with treatment in children postoperatively. This study included children ages 7 to 16 years undergoing surgery associated with postoperative pain. One to 4 observations were recorded in each child within the first 24 hours postoperatively. At each assessment, children rated their pain with the NRS, stated their PNM, and rated their satisfaction with pain management. Assessments were repeated within 1 to 2 hours, and children additionally rated their PR as the same, better, or worse in comparison with the earlier assessment. Receiver operator characteristic curves were developed to examine potential NRS cut-points for PNM and PS, and the minimum clinically significant difference (MCSD) in pain score associated with PR was calculated. Three hundred ninety-seven observations (including 189 pairs) were recorded in 113 children. NRS scores associated with PNM were significantly higher than "no need" (median 6 vs. 3; P < 0.001). NRS scores >4 had good sensitivity (0.81) and specificity (0.70) to discriminate PNM, but with a large number of false positives and negatives (e.g., 42% of children with scores >4 did not need analgesia). The MCSD in NRS scores was -1 (95% confidence interval [CI] -0.5 to 1) or +1 (CI 0.5 to 2.7) in relation to feel "a little better" or "worse," respectively (P < 0.001 vs. the same). NRS scores >6 had a sensitivity of 0.82 and specificity of 0.76 in discriminating dissatisfaction with treatment, yet 46% and 24% of children with scores >6, respectively, were somewhat to very satisfied with their analgesia. This study provides important information regarding the clinical interpretation of NRS pain scores in children. Data further support the NRS as a valid measure of pain intensity in relation to the child's PNM, PR, and PS in the acute postoperative setting. However, the variability in scores in relation to other clinically meaningful outcomes suggests that application of cut-points for individual treatment decisions is inappropriate.
Canadian Journal of Anaesthesia Journal Canadien D Anesthesie, May 1, 2002
P Pu ur rp po os se e: : To determine if low-dose ketorolac would improve analgesia while minimiz... more P Pu ur rp po os se e: : To determine if low-dose ketorolac would improve analgesia while minimizing unwanted side effects in adolescents following posterior spinal fusion (PSF).
Two recent studies have identified copious secretions as an independent risk factor for periopera... more Two recent studies have identified copious secretions as an independent risk factor for perioperative adverse events in children who present for elective surgery in the presence of an upper respiratory tract infection (URI). We designed this study, therefore, to determine whether the administration of the anticholinergic drug, glycopyrrolate, to children with URIs would reduce the incidence of adverse perioperative respiratory events. One hundred thirty children (1 mo to 18 yr of age) who presented for elective surgery with a URI were randomized to receive either 0.01 mg/kg glycopyrrolate or placebo and were followed for the appearance and severity of any perioperative respiratory adverse events. The two groups were similar with respect to demographics, presenting URI symptoms, anesthetic management, and surgical procedure. In the intention-to-treat analysis, there were no statistical differences in the incidence or severity of perioperative respiratory adverse events between the glycopyrrolate and placebo groups (45.2% vs 37.5% respectively, P = NS). Furthermore, there were no differences in outcome between the two groups when children with congestion and secretions were analyzed separately (45.0% vs 37.0%, respectively). However, compared with the placebo group, children in the glycopyrrolate group had significantly shorter discharge times (83.9 min vs 111.4 min, P = 0.024), and significantly less postoperative nausea and vomiting (10.7% vs 33.3%, P = 0.005). These results suggest that glycopyrrolate, administered after induction of anesthesia to children with URIs, does not reduce the incidence of perioperative respiratory adverse events, and thus may not be clinically indicated for routine use in this population.
The purpose of this study was to further test the validity of the Faces, Legs, Activity, Cry and ... more The purpose of this study was to further test the validity of the Faces, Legs, Activity, Cry and Consolability (FLACC) Behavioral Pain Assessment Scale for use with children. Thirty children aged 3-7 years (5.01 +/- 1.44) who had undergone a variety of surgical procedures were observed and assessed for pain intensity at 20 + 2 hours after surgery. FLACC scores were assigned by one of the nurse investigators, and a self-report of pain using the FACES scale was obtained from the child. There were significant and positive correlations between the FLACC and FACES scores for the entire sample and for the scores of children 5-7 years of age, but not for children < age 5. These findings provide additional support for the construct validity of the FLACC Pain Assessment Tool.
The ability to assess accurately the risks and benefits of a study are important to ensure that t... more The ability to assess accurately the risks and benefits of a study are important to ensure that the subject can make an informed decision regarding his or her own or his or her surrogate's participation. This study was designed to examine factors that influence parents' assessments of the risks and benefits of anesthesia and surgery research involving their children. The study population consisted of parents of 505 children who had been approached to participate in 1 of several ongoing clinical studies. Regardless of their decision to allow or decline their child's participation in a study, parents completed a questionnaire that elicited information regarding their perceptions of the risks and benefits of the study and factors that had influenced their decision. Factors that influenced positive risk/benefit assessments by the parents included use of a placebo, the designated risk category of the study, the clarity of information given, the parents' perceptions of the amount of time provided to make a decision, and the amount of privacy afforded them in making a decision. Furthermore, positive risk/benefit assessments were associated with low decisional uncertainty and greater trust in the medical system. Identification of factors that influence parents' perceptions of the risks and benefits of a research study is important as a means to optimize the manner in which consent information is disclosed and to ensure that parents and subjects can assess accurately the relative importance of the risks and benefits.
To evaluate the reliability and validity of the FLACC Pain Assessment Tool which incorporates fiv... more To evaluate the reliability and validity of the FLACC Pain Assessment Tool which incorporates five categories of pain behaviors: facial expression; leg movement; activity; cry; and consolability. Eighty-nine children aged 2 months to 7 years, (3.0 +/- 2.0 yrs.) who had undergone a variety of surgical procedures, were observed in the Post Anesthesia Care Unit (PACU). The study consisted of: 1) measuring interrater reliability; 2) testing validity by measuring changes in FLACC scores in response to administration of analgesics; and 3) comparing FLACC scores to other pain ratings. The FLACC tool was found to have high interrater reliability. Preliminary evidence of validity was provided by the significant decrease in FLACC scores related to administration of analgesics. Validity was also supported by the correlation with scores assigned by the Objective Pain Scale (OPS) and nurses' global ratings of pain. The FLACC provides a simple framework for quantifying pain behaviors in children who may not be able to verbalize the presence or severity of pain. Our preliminary data indicates the FLACC pain assessment tool is valid and reliable.
Background: The purpose of this retrospective study was to examine the benefits, risks and costs ... more Background: The purpose of this retrospective study was to examine the benefits, risks and costs associated with aprotinin use in children who underwent repair of an atrial septal defect (ASD). The primary aim was to determine whether the transfusion rate is lower in children who received aprotinin compared with those who did not during ASD repair. The use of aprotinin has been shown to reduce transfusion requirements for children undergoing primary or secondary repair of congenital cardiac anomalies. However, past studies have not reported the benefits of this agent during low complexity procedures such as ASD repair. Methods: All children who underwent ASD repair over 6 years (3 years pre-and postroutine use of aprotinin for all CPB cases in the institution) were identified, and their medical records reviewed. Children with multiple congenital cardiac lesions were excluded. The following data were recorded: demographics and baseline laboratory findings, intraoperative use of aprotinin, cardiopulmonary bypass information including details of ultrafiltration, all intraoperative and postoperative transfusions, postoperative bleeding and relevant laboratory findings. Results: One hundred and fifteen children were included, 66 of whom received aprotinin. Transfusion rates were not different between children who received aprotinin [n = 8 (12%)] and those who did not [n = 3 (6%)]. Furthermore, changes in hematocrit were not different between groups. These findings were similar when children £15 kg were compared with those >15 kg. Conclusions: This study suggests that aprotinin use offers no benefit for children undergoing isolated repair of an ASD.
of hospital-wide monitoring standards, a quality assurance (QA) tool was prospectively completed ... more of hospital-wide monitoring standards, a quality assurance (QA) tool was prospectively completed for 1140 children (aged 2.96 ? 3.7 yr) sedated for procedures by nonanesthesiologists.
P Pu ur rp po os se e: : To determine if low-dose ketorolac would improve analgesia while minimiz... more P Pu ur rp po os se e: : To determine if low-dose ketorolac would improve analgesia while minimizing unwanted side effects in adolescents following posterior spinal fusion (PSF).
Background: Otherwise healthy children who present for elective surgery with an upper respiratory... more Background: Otherwise healthy children who present for elective surgery with an upper respiratory infection (URI) may be at risk for perioperative respiratory complications. This risk may be increased in children with congenital heart disease who undergo cardiac surgery while harboring a URI because of their compromised cardiopulmonary status. Therefore, this study was designed to determine the incidence of peri-and postoperative complications in children undergoing cardiac surgery while harboring a URI.
Participation of children in clinical research requires not only parental permission but also the... more Participation of children in clinical research requires not only parental permission but also the assent of the child. Although there is no fixed age at which assent should be sought, investigators should obtain assent from children considered able to provide it. This study was designed to determine children's understanding of the elements of disclosure for studies in which they had assented to participate. The study population included 102 children aged 7-18 yr who had given their assent to participate in a clinical anesthesia or surgical study. Children were interviewed using a semistructured format to determine their understanding of eight core elements of disclosure for the study to which they had agreed to participate. Two independent assessors scored the children's levels of understanding of these elements. The children's perceived level of understanding of the elements of disclosure was significantly greater than their measured understanding (7.0 +/- 2.4 vs 5.3 +/- 2.7, 0-10 scale; P< 0.0001). Complete understanding of the elements of disclosure for all children ranged from 30.4 to 89.4%. Children aged more than 11 yr had significantly greater understanding compared with younger children, particularly with respect to understanding of the study protocol, the benefits, and the freedom to withdraw. Children approached for their assent to participate in a clinical anesthesia or surgery study have limited understanding of the elements of disclosure and their role as a research participant, particularly if they are aged less than 11 yr.
... have been discussed. Alan R. Tait, Ph.D.*. Shobha Malviya, MD. Terri Voepel-Lewis, MSN, RN. .... more ... have been discussed. Alan R. Tait, Ph.D.*. Shobha Malviya, MD. Terri Voepel-Lewis, MSN, RN. ... assumptions correct? Katz, V; Balderston, K; DeFreest, M American Journal of Obstetrics and Gynecology, 192(6): 1916-1920. 10.1016 ...
Self-reported pain scores are used widely in clinical and research settings, yet little is known ... more Self-reported pain scores are used widely in clinical and research settings, yet little is known about their interpretability in children. In this prospective, observational study we evaluated the relationship between 0 to 10 numerical rating scale (NRS) pain scores and other self-reported, clinically meaningful outcomes, including perceived need for medicine (PNM), pain relief (PR), and perceived satisfaction (PS) with treatment in children postoperatively. This study included children ages 7 to 16 years undergoing surgery associated with postoperative pain. One to 4 observations were recorded in each child within the first 24 hours postoperatively. At each assessment, children rated their pain with the NRS, stated their PNM, and rated their satisfaction with pain management. Assessments were repeated within 1 to 2 hours, and children additionally rated their PR as the same, better, or worse in comparison with the earlier assessment. Receiver operator characteristic curves were developed to examine potential NRS cut-points for PNM and PS, and the minimum clinically significant difference (MCSD) in pain score associated with PR was calculated. Three hundred ninety-seven observations (including 189 pairs) were recorded in 113 children. NRS scores associated with PNM were significantly higher than "no need" (median 6 vs. 3; P < 0.001). NRS scores >4 had good sensitivity (0.81) and specificity (0.70) to discriminate PNM, but with a large number of false positives and negatives (e.g., 42% of children with scores >4 did not need analgesia). The MCSD in NRS scores was -1 (95% confidence interval [CI] -0.5 to 1) or +1 (CI 0.5 to 2.7) in relation to feel "a little better" or "worse," respectively (P < 0.001 vs. the same). NRS scores >6 had a sensitivity of 0.82 and specificity of 0.76 in discriminating dissatisfaction with treatment, yet 46% and 24% of children with scores >6, respectively, were somewhat to very satisfied with their analgesia. This study provides important information regarding the clinical interpretation of NRS pain scores in children. Data further support the NRS as a valid measure of pain intensity in relation to the child's PNM, PR, and PS in the acute postoperative setting. However, the variability in scores in relation to other clinically meaningful outcomes suggests that application of cut-points for individual treatment decisions is inappropriate.
Canadian Journal of Anaesthesia Journal Canadien D Anesthesie, May 1, 2002
P Pu ur rp po os se e: : To determine if low-dose ketorolac would improve analgesia while minimiz... more P Pu ur rp po os se e: : To determine if low-dose ketorolac would improve analgesia while minimizing unwanted side effects in adolescents following posterior spinal fusion (PSF).
Two recent studies have identified copious secretions as an independent risk factor for periopera... more Two recent studies have identified copious secretions as an independent risk factor for perioperative adverse events in children who present for elective surgery in the presence of an upper respiratory tract infection (URI). We designed this study, therefore, to determine whether the administration of the anticholinergic drug, glycopyrrolate, to children with URIs would reduce the incidence of adverse perioperative respiratory events. One hundred thirty children (1 mo to 18 yr of age) who presented for elective surgery with a URI were randomized to receive either 0.01 mg/kg glycopyrrolate or placebo and were followed for the appearance and severity of any perioperative respiratory adverse events. The two groups were similar with respect to demographics, presenting URI symptoms, anesthetic management, and surgical procedure. In the intention-to-treat analysis, there were no statistical differences in the incidence or severity of perioperative respiratory adverse events between the glycopyrrolate and placebo groups (45.2% vs 37.5% respectively, P = NS). Furthermore, there were no differences in outcome between the two groups when children with congestion and secretions were analyzed separately (45.0% vs 37.0%, respectively). However, compared with the placebo group, children in the glycopyrrolate group had significantly shorter discharge times (83.9 min vs 111.4 min, P = 0.024), and significantly less postoperative nausea and vomiting (10.7% vs 33.3%, P = 0.005). These results suggest that glycopyrrolate, administered after induction of anesthesia to children with URIs, does not reduce the incidence of perioperative respiratory adverse events, and thus may not be clinically indicated for routine use in this population.
The purpose of this study was to further test the validity of the Faces, Legs, Activity, Cry and ... more The purpose of this study was to further test the validity of the Faces, Legs, Activity, Cry and Consolability (FLACC) Behavioral Pain Assessment Scale for use with children. Thirty children aged 3-7 years (5.01 +/- 1.44) who had undergone a variety of surgical procedures were observed and assessed for pain intensity at 20 + 2 hours after surgery. FLACC scores were assigned by one of the nurse investigators, and a self-report of pain using the FACES scale was obtained from the child. There were significant and positive correlations between the FLACC and FACES scores for the entire sample and for the scores of children 5-7 years of age, but not for children < age 5. These findings provide additional support for the construct validity of the FLACC Pain Assessment Tool.
The ability to assess accurately the risks and benefits of a study are important to ensure that t... more The ability to assess accurately the risks and benefits of a study are important to ensure that the subject can make an informed decision regarding his or her own or his or her surrogate's participation. This study was designed to examine factors that influence parents' assessments of the risks and benefits of anesthesia and surgery research involving their children. The study population consisted of parents of 505 children who had been approached to participate in 1 of several ongoing clinical studies. Regardless of their decision to allow or decline their child's participation in a study, parents completed a questionnaire that elicited information regarding their perceptions of the risks and benefits of the study and factors that had influenced their decision. Factors that influenced positive risk/benefit assessments by the parents included use of a placebo, the designated risk category of the study, the clarity of information given, the parents' perceptions of the amount of time provided to make a decision, and the amount of privacy afforded them in making a decision. Furthermore, positive risk/benefit assessments were associated with low decisional uncertainty and greater trust in the medical system. Identification of factors that influence parents' perceptions of the risks and benefits of a research study is important as a means to optimize the manner in which consent information is disclosed and to ensure that parents and subjects can assess accurately the relative importance of the risks and benefits.
To evaluate the reliability and validity of the FLACC Pain Assessment Tool which incorporates fiv... more To evaluate the reliability and validity of the FLACC Pain Assessment Tool which incorporates five categories of pain behaviors: facial expression; leg movement; activity; cry; and consolability. Eighty-nine children aged 2 months to 7 years, (3.0 +/- 2.0 yrs.) who had undergone a variety of surgical procedures, were observed in the Post Anesthesia Care Unit (PACU). The study consisted of: 1) measuring interrater reliability; 2) testing validity by measuring changes in FLACC scores in response to administration of analgesics; and 3) comparing FLACC scores to other pain ratings. The FLACC tool was found to have high interrater reliability. Preliminary evidence of validity was provided by the significant decrease in FLACC scores related to administration of analgesics. Validity was also supported by the correlation with scores assigned by the Objective Pain Scale (OPS) and nurses' global ratings of pain. The FLACC provides a simple framework for quantifying pain behaviors in children who may not be able to verbalize the presence or severity of pain. Our preliminary data indicates the FLACC pain assessment tool is valid and reliable.
Uploads
Papers by Shobha Malviya