Steven J. Weisman

Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations

UNLABELLED Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains and measures that should be considered in clinical trials of treatments for acute and chronic pain in children and adolescents. Consensus was refined by consultation with the international pediatric pain community through announcement of our recommendations on the Pediatric Pain List and inviting and incorporating comments from external sources. There was consensus that investigators conducting pediatric acute pain clinical trials should consider assessing outcomes in pain intensity; global judgment of satisfaction with treatment; symptoms and adverse events; physical recovery; emotional response; and economic factors. There was also agreement that investigators conducting pediatric clinical trials in chronic and recurrent pain should consider assessing outcomes in pain intensity; physical functioning; emotional functioning; role functioning; symptoms and adverse events; global judgment of satisfaction with treatment; sleep; and economic factors. Specific measures or measurement strategies were recommended for different age groups for each domain. PERSPECTIVE Based on systematic review and consensus of experts, core domains and measures for clinical trials to treat pain in children and adolescents were defined. This will assist in comparison and pooling of data and promote evidence-based treatment, encourage complete reporting of outcomes, simplify the review of proposals and manuscripts, and facilitate clinicians making informed decisions regarding treatment.

Premedication in the United States: a status report.

We undertook a mailing survey study to assess the current practice of sedative premedication in anesthesia.A total of 5396 questionnaires were mailed to randomly selected physician members of the American Society of Anesthesiologists. Forty-six percent (n = 2421) of those sampled returned the questionnaire after two mailings. The reported rate of sedative premedication in the United States varied widely among age groups and geographical locations. Premedicant sedative drugs were least often used with children younger than age 3 years and most often used with adults less than 65 years of age (25% vs 75%, P = 0.001). Midazolam was the most frequently used premedicant both in adults and children (>75%). When analyzed based on geographical locations, use of sedative premedicants among adults was least frequent in the Northeast region and most frequent in the Southeast region (50% vs 90%, P = 0.001). When the frequency of premedication was examined against health maintenance organization (HMO) penetration (i.e., HMO enrollment by total population) in the various geographical regions, correlation coefficients (r) ranged from -0.96 to -0.54. Multivariable analysis revealed that HMO penetration is an independent predictor for the use of premedication in adults and children. The marked variation among geographical areas in premedicant usage patterns under-scores the lack of consensus among anesthesiologists about the need for premedication. The data suggest that HMO participation may affect delivery of this component of anesthetic care. (Anesth Analg 1997;84:427-32)

Electroacupuncture Prophylaxis of Postoperative Nausea and Vomiting following Pediatric Tonsillectomy with or without Adenoidectomy

Background Electrical stimulation of acupuncture point P6 reduces the incidence of postoperative nausea or vomiting (PONV) in adult patients. However, acupressure, laser stimulation of P6, and acupuncture during anesthesia have not been effective for reducing PONV in the pediatric population. The authors studied the effect of electrical P6 acupuncture in awake pediatric patients who had undergone surgery associated with a high incidence of PONV. Methods Patients aged 4–18 yr undergoing tonsillectomy with or without adenoidectomy were randomly assigned to acupuncture, sham acupuncture, or control groups. Acupuncture needles at P6 and a neutral point were placed while patients were anesthetized, and low-frequency electrical stimulation was applied to these points for 20 min in the recovery room while the patients were awake (P6 Acu group). This treatment was compared with sham needles along the arm at acupuncture points not associated with antiemesis (sham group) and a no-needle control group. The arms were wrapped to prevent identification of treatment group, and anesthetic, analgesic, and surgical technique were standardized. Assessed outcomes were occurrence of nausea, occurrence and number of episodes of vomiting, time to vomiting, and use of antiemetic rescue medication. Results One hundred twenty patients were enrolled in the study, 40 per group. There were no differences in age, weight, sex, or opioid administration between groups. The PONV incidence was significantly lower with P6 acupuncture (25 of 40 or 63%; odds ratio, 0.135; number needed to treat, 3.3;P < 0.001) compared with controls (37 of 40 or 93%). Sham puncture had no effect on PONV (35 of 40 or 88%;P = not significant). Occurrence of nausea was significantly less in P6 Acu (24 of 40 or 60%; odds ratio, 0.121;P < 0.01), but not in the sham group (34 of 40 or 85%) compared with the control group (37 of 40 or 93%). Vomiting occurred in 25 of 40 or 63% in P6 Acu; 35 of 40 or 88% in the sham group, and 31 in 40 or 78% in the control group (P = not significant). Patients receiving sham puncture vomited significantly earlier (P < 0.02) and needed more rescue treatment (33 of 40 or 83%; odds ratio, 3.48;P < 0.02) compared with P6 Acu (23 of 40 or 58%) and the control group (24 of 40 or 60%). Conclusions Perioperative P6 electroacupuncture in awake patients significantly reduced the occurrence of nausea compared with the sham and control groups, but it did not significantly reduce the incidence or number of episodes of emesis or the use of rescue antiemetics. Sham acupuncture may exacerbate the severity but not the incidence of emesis. The efficacy of P6 acupuncture for PONV prevention is similar to commonly used pharmacotherapies. Its appropriate role in prevention and treatment of PONV requires further study.

A Randomized Clinical Trial of Ibuprofen Versus Acetaminophen With Codeine for Acute Pediatric Arm Fracture Pain

STUDY OBJECTIVE We compare the treatment of pain in children with arm fractures by ibuprofen 10 mg/kg versus acetaminophen with codeine 1 mg/kg/dose (codeine component). METHODS This was a randomized, double-blind, clinical trial of children during the first 3 days after discharge from the emergency department (ED). The primary outcome was failure of the oral study medication, defined as use of the rescue medication. Pain medication use, pain scores, functional outcomes, adverse effects, and satisfaction were also assessed. RESULTS Three hundred thirty-six children were randomized to treatment, 169 to ibuprofen and 167 to acetaminophen with codeine; 244 patients were analyzed. Both groups used a median of 4 doses (interquartile range 2, 6.5). The proportion of treatment failures for ibuprofen (20.3%) was lower than for acetaminophen with codeine (31.0%), though not statistically significant (difference=10.7%; 95% confidence interval -0.2 to 21.6). The proportion of children who had any function (play, sleep, eating, school) affected by pain when pain was analyzed by day after injury was significantly lower for the ibuprofen group. Significantly more children receiving acetaminophen with codeine reported adverse effects and did not want to use it for future fractures. CONCLUSION Ibuprofen was at least as effective as acetaminophen with codeine for outpatient analgesia for children with arm fractures. There was no significant difference in analgesic failure or pain scores, but children receiving ibuprofen had better functional outcomes. Children receiving ibuprofen had significantly fewer adverse effects, and both children and parents were more satisfied with ibuprofen. Ibuprofen is preferable to acetaminophen with codeine for outpatient treatment of children with uncomplicated arm fractures.

Septicemia in pediatric oncology patients: the significance of viridans streptococcal infections.

One hundred nine consecutive episodes of septicemia were retrospectively evaluated in 61 children with malignancy. In addition, the records of all pediatric oncology patients who received high-dose cytarabine (HDAC) chemotherapy were reviewed. Gram-positive organisms accounted for 82.6% of the septicemic episodes. In the total group, coagulase-negative staphylococci and viridans streptococci accounted for 35.8% and 28.4% of the episodes, respectively. In granulocytopenic patients, viridans streptococci were the most common pathogens (36.8%). In the subset of patients who received HDAC, 62.5% of the septicemic episodes were caused by viridans streptococci. Pulmonary complications developed in nine (29%) of the total cases of viridans streptococcal sepsis, whereas these complications occurred in only eight (10.3%) of the septic episodes caused by other organisms. In patients who had viridans septicemia, prior treatment with HDAC did not increase the incidence of pulmonary complications. In septic children with malignancy, our results demonstrate a high incidence of gram-positive organisms, including viridans streptococci, which were once regarded as culture contaminants.

Social adaptability, cognitive abilities, and other predictors for children’s reactions to surgery

STUDY OBJECTIVE To examine the relationship between social adaptability, cognitive abilities, and other personality characteristics to perioperative anxiety. STUDY DESIGN Prospective cohort investigation. PATIENTS 60 children ASA physical status I and II, age 3 to 10 years. SETTING Tertiary care childrens hospital. MEASUREMENTS Temperament (EASI), cognitive abilities (KABC), and adaptive behavior (Vineland) were evaluated in a group of children undergoing surgery. Parental coping style (MBBS) and parental state (STAI-S) and trait (STAI-T) anxiety were assessed as well. On the day of surgery, anxiety of the child was measured at the preoperative holding area and during induction of anesthesia (m-YPAS). MAIN RESULTS Univariate correlational analysis demonstrated that young age (r = -0.27), poor social adaptability (Vineland) (r = -0.38), shy and inhibited personality (EASI; temperament) (r = -0.33), higher intelligence (KABC) (r = 0.29), increased parental anxiety (r = 0.44), and parental high-monitoring coping style (r = -0.25) are all associated with higher levels of perioperative anxiety. Stepwise multivariate regression analysis has demonstrated that controlling for the variables above, parental anxiety (p = 0.004), childs social adaptive capabilities (p = 0.04), and childs temperament (sociability) (p = 0.04) are independent predictors for increased perioperative anxiety (R(2) = 0.38, F = 5.5, p = 0.003). CONCLUSIONS Anesthesiologists need to pay close attention to the families of pediatric surgical children who are socially maladjusted, shy and inhibited, and have anxious parents.

Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial.

BACKGROUND: Gabapentin has opioid-sparing effects in adult surgical patients, but no reported studies have involved children and adolescents. In a double-blind, randomized, controlled trial, we examined whether gabapentin decreases postoperative opioid consumption for pediatric spinal fusion patients with idiopathic scoliosis. METHODS: Patients, aged 9 to 18 years, received preoperative gabapentin (15 mg/kg, treatment) or placebo. Anesthesia was standardized. After surgery, all patients received standardized patient-controlled analgesia opioid and continued on either gabapentin (5 mg/kg) or placebo 3 times per day for 5 days. Opioid use was calculated in mg/kg/time intervals. Pain scores and opioid side effects were recorded. RESULTS: Data from 59 patients (30 placebo and 29 gabapentin) did not differ in demographics. Total morphine consumption (mg/kg/h ± SD) was significantly lower in the gabapentin group in the recovery room (0.044 ± 0.017 vs 0.064 ± 0.031, P = 0.003), postoperative day 1 (0.046 ± 0.016 vs 0.055 ± 0.017, P = 0.051), and postoperative day 2 (0.036 ± 0.016 vs 0.047 ± 0.019, P = 0.018). In addition, gabapentin significantly reduced first pain scores in the recovery room (2.5 ± 2.8 vs 6.0 ± 2.4, P < 0.001) and the morning after surgery (3.2 ± 2.6 vs 5.0 ± 2.2, P < 0.05), but otherwise pain scores were not significantly different. There were no differences in opioid-related side effects over the course of the study. CONCLUSION: Perioperative oral gabapentin reduced the amount of morphine used for postoperative pain after spinal fusion surgery, but not overall opioid-related side effects. Initial pain scores were lower in the treatment group. Perioperative use of gabapentin seems to be an effective adjunct to improve pain control in the early stages of recovery in children and adolescents undergoing spinal fusion.

A prospective evaluation of opioid weaning in opioid-dependent pediatric critical care patients.

Critically ill children are treated with opioid medication in an attempt to decrease stress and alleviate pain during prolonged pediatric intensive care. This treatment plan places children at risk for opioid dependency. Once dependent, children need to be weaned or risk development of a withdrawal syndrome on abrupt cessation of medication. We enrolled opioid-dependent children into a prospective, randomized trial of 5- versus 10-day opioid weaning using oral methadone. Children exposed to opioids for an average of 3 wk showed no difference in the number of agitation events requiring opioid rescue (3 consecutive neonatal abstinence scores >8 every 2 h) in either wean group. Most of the events requiring rescue occurred on day 5 and 6 of the wean in both treatment groups. Patients may be able to be weaned successfully in 5 days once converted to oral methadone, with a follow-up period after medication wean to observe for a delayed withdrawal syndrome.

Gabapentin in Phantom Limb Pain Management in Children and Young Adults: Report of Seven Cases

Seven children and young adults with phantom limb pain (PLP) were treated with gabapentin. PLP resolved in six patients within two months. One patient still had symptoms to a lesser degree. Mean follow up time was 1.74 years. Gabapentin may be a useful adjunct to pain management in patients with PLP symptoms.

The Impact of Pediatric Chronic Pain on Parents’ Health-Related Quality of Life and Family Functioning: Reliability and Validity of the PedsQL 4.0 Family Impact Module

OBJECTIVE To evaluate the psychometric properties of the Family Impact Module (FIM), a parent self-report measure of health-related quality of life (HRQOL) and family functioning, among parents of youth with chronic pain. METHODS Parents (N = 458) completed the FIM (Total Impact, HRQOL, and Family Functioning scales); parents and youth (N = 332) completed measures of pain catastrophizing, pediatric quality of life, and emotional/behavioral functioning. RESULTS The FIM demonstrated strong internal consistency and item-total correlations. All FIM scales were positively associated with pain catastrophizing, functional disability, and emotional/behavioral problems; and inversely related to pediatric quality of life. Mothers reported significantly worse HRQOL than fathers. Mothers and fathers did not differ on reports of Family Functioning. HRQOL and Family Functioning did not differ as a function of pain diagnosis. CONCLUSION The FIM appears to be a suitable measure of parent self-reported HRQOL and family functioning in pediatric chronic pain.