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Biomedical subjects

T P Barden

Publications and source records attributed to T P Barden.

At least 19 recordsLinked to original sources

Analgesic efficacy and potency of two oral controlled-release morphine preparations.

MS Contin tablets and Oramorph SR tablets are two forms of oral controlled-release morphine sulfate available for the alleviation of pain. Our objective was to compare their analgesic effects in a relative potency assay. In this study, 151 patients undergoing caesarean section or abdominal hysterectomy and reporting moderate or severe postoperative pain received a 30 or 90 mg dose of either drug in a balanced, randomized, double-blind, parallel-group, single-dose experimental design. Patients provided self-ratings of analgesia. Relative potency for pain relief were calculated from log dose-effect curves. For total pain relief (rated by visual analog scales) over 12 hours, the log dose relative potency estimate for MS Contin tablets/Oramorph SR tablets was 1.9 (95% confidence limits, 0.89 to 11.1); for peak pain relief (visual analog scales) the relative potency estimate was 1.7 (95% confidence limits, 0.65 to 48.3). Overall, the 90 mg dose of MS Contin was more effective than 30 or 90 mg doses of Oramorph SR and the 30 mg dose of MS Contin at hours 6 to 12. Adverse experiences (mainly drowsiness) were mostly mild to moderate, with no significant differences in their overall incidence or severity between equivalent doses. MS Contin tablets provided greater peak, total, and duration of analgesia, without higher incidence of adverse experiences.

Administration, Oral↗

Anirolac vs. naproxen for postpartum uterine pain.

Anirolac, a new nonsteroidal anti-inflammatory drug, was evaluated for relative efficacy, safety, and time course of analgesia. In a stratified, randomized, parallel, double-blind trial, 120 hospitalized women with moderate or severe postpartum uterine pain were treated with single oral doses of anirolac, 50 or 100 mg, naproxen sodium, 550 mg, or placebo. Using verbal scales, patients rated pain intensity, pain relief, and side effects at regular intervals for 6 hours. Highest summed analgesic ratings over placebo were induced by anirolac, 100 mg (P less than or equal to 0.001), and naproxen (P less than or equal to 0.001), followed by anirolac, 50 mg (P less than or equal to 0.005). At each assessment after the first hour, anirolac, 50 and 100 mg, and naproxen induced significantly stronger analgesia than did placebo. Statistically significantly more drowsiness was reported with all three active agents than with placebo. Our results suggest that, for postpartum uterine pain, analgesia with anirolac, 50 or 100 mg, is equivalent to that with naproxen, 550 mg.

Administration, Oral↗

Flurbiprofen, aspirin, codeine, and placebo for postpartum uterine pain.

Flurbiprofen (Ansaid, Upjohn), a substituted phenyl propionic acid, is a new analgesic/anti-inflammatory agent. To evaluate its relative efficacy in noninflammatory pain, 159 hospitalized women with moderate or severe postpartum uterine cramps were given single oral doses of 50 mg of flurbiprofen, 650 mg of aspirin, 60 or 120 mg of codeine sulfate, or placebo in a parallel, stratified, randomized block, placebo-controlled, double-blind trial. Patients rated pain intensity, pain relief, and side effects in uniform interviews for six hours after treatment. All measures of peak and summed analgesia exhibited significant differences among the five treatments. Flurbiprofen and aspirin showed the greatest analgesic response and were significantly superior to placebo. Results of codeine treatment were equivocal with no evidence of a positive dose response. Side effects were unremarkable except for dizziness and drowsiness after the 120-mg codeine dose. These findings suggest that flurbiprofen as an analgesic for patients with postpartum uterine pain is equivalent to aspirin and superior to codeine.

Adult↗

Relationship of nonstress test reactivity and gestational age.

The relationship between gestational age and reactivity during the nonstress test was evaluated in 297 high-risk patients. When the incidence of nonreactive tests at gestational ages of 28 to 44 weeks was evaluated week-by-week, either on the basis of tests performed or patients tested, there was no statistically significant relationship between reactivity and gestational age (P = .184 tests; P = .222 patients). Four grouped gestational-age intervals were evaluated. Interval A consisted of the period from 28 to 32 weeks' gestation, interval B consisted of the period from 33 to 36 weeks' gestation, interval C consisted of the period from 37 to 41 weeks' gestation, and interval D consisted of the period from 42 to 44 weeks' gestation. The incidences of nonreactive tests were 15.3, 3.9, 2.5, and 5.9% in intervals A, B, C, and D, respectively. The differences in the incidences of nonreactive tests between those performed in intervals A and B and intervals A and C were highly statistically significant (P less than .001). Differences in the incidences between other intervals did not reach statistical significance. The incidences of patients who experienced a nonreactive test were 10.2, 2.4, 2.8, and 4.7% in intervals A, B, C, and D, respectively. The differences in the incidences of patients who experienced a nonreactive test in intervals A and B and intervals A and C were highly statistically significant (P less than .001). Differences in the incidences between other intervals did not reach statistical significance.(ABSTRACT TRUNCATED AT 250 WORDS)

Female↗

Clinical experience with one hundred seven diabetic pregnancies.

Clinical experience with 45 pregnancies in women with Class A diabetes and 62 pregnancies in women with insulin-requiring diabetes is described. The perinatal mortality rates were 0, 16.1, and 9.3, respectively, among the Class A, insulin-requiring, and total diabetic populations. Diabetic mothers experienced significantly higher prevalences of cesarean section and ketoacidosis than did the overall population. There were no other significant differences in maternal complications. Diabetic mothers demonstrated high rates of abnormal estriol levels and relatively low rates of positive contraction stress tests. Positive contraction stress tests were highly correlated with abnormal outcome. Delivery occurred either at or after 37 weeks in 93% of the Class A and in 81% of the insulin-requiring women. In comparison to infants in the general population, those of diabetic mothers experienced significantly elevated rates of being large for gestational age, macrosomia, and hypoglycemia. Congenital abnormalities were significantly higher in the Class A, but not in the insulin-requiring population. Neonatal morbidity could not be related to maternal diabetic control and was only minimally related to gestational age.

Blood Glucose↗

Metkephamid and meperidine analgesia after episiotomy.

Metkephamid is an analog of methionine enkephalin. The efficacy, safety, and time course of analgesia with 70 or 140 mg metkephamid were compared with those of 100 mg meperidine and placebo in 59 hospitalized women with severe postpartum episiotomy pain. There were two separate trials with single intramuscular doses and identical designs, including parallel groups, randomized blocks, and double-blind conditions. Using subjective reports as indexes of response, patients rated pain intensity, pain relief, and side effects at periodic interviews for 6 hr. Almost all measures of summed and peak analgesia exhibited important differences among the three treatments in both trials. Metkephamid at the 140-mg dose was the most effective and meperidine, 100 mg, was next, whereas metkephamid, 70 mg, and placebo were least effective. Only metkephamid, 140 mg, and meperidine were measurably superior to placebo. Both treatments took effect within 30 min and peaked at 1 to 2 hr; with 140 mg metkephamid, maximum analgesia was sustained 6 hr, i.e., 2 hr longer than with meperidine. Metkephamid, 70 mg, could not be distinguished from placebo throughout its entire time course. Although dizziness was experienced with meperidine, the two metkephamid doses induced other side effects, including sensation of heavy limbs, dry mouth, eye redness, and nasal stuffiness. None were distressing. Our results suggest that 140 mg metkephamid compares favorably with 100 mg meperidine for analgesia after episiotomy, but it induces minor side effects more frequently.

Adolescent↗

Codeine and aspirin analgesia in postpartum uterine cramps: qualitative aspects of quantitative assessments.

The analgesic response to codeine of patients with postpartum uterine-cramp pain has recently met with controversy. To readdress this question, we conducted a new study comparing codeine sulfate, 60 mg (N = 32) and 120 mg (N = 31), with aspirin, 650 mg (N = 34), and placebo (N = 32) in hospitalized women with moderate or severe postpartum uterine cramps treated with single oral doses in a parallel, stratified, randomized, double-blind trial. Subjective reports were used as indices of response, and patients rated pain intensity, pain relief, and side effects at periodic, uniformly conducted interviews for 6 hr. Most measures of analgesia exhibited important differences among the treatments. In patients with undifferentiated pain (N = 129) and in a subset of patients with pure uterine cramps (N = 56; i.e., no concomitant episiotomy), aspirin showed the greatest response, whereas codeine responses were equivocal with no evidence of a positive dose response. In contrast, in a subset of patients with mixed episiotomy-uterine pain (N = 73), 120 mg codeine showed good separation from placebo and compared favorably with aspirin. Codeine, 60 mg, showed a similar trend, and there was a strong suggestion of dose-dependent analgesia. Side effects were not remarkable except for dizziness and drowsiness after 120 mg codeine in all sets and subsets of patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

The epidemiology of genital colonization with Staphylococcus aureus.

The prevalence of genital colonization with Staphylococcus aureus, including strains that have been associated with toxic shock syndrome, was studied in 600 women. Nine percent of these women were colonized with S. aureus, 5% of whom had positive vaginal cultures, and 1% were colonized with toxin-producing strains. Black women were colonized with S. aureus, including toxin-producing strains, as frequently or more frequently than white women. The highest colonization rates occurred in postpartum women. Trends toward increasing colonization occurred in relation to decreasing age and socioeconomic status. There were no statistically significant relationships between genital colonization with S. aureus and the use of tampons, oral contraceptives, or a variety of other personal habits and health problems. Genital cultures taken in consecutive menstrual cycles indicated that 35% of women with S. aureus were persistent carriers, and the rest either intermittent or transient carriers. Toxin-producing S. aureus was also identified in family members of women carrying the same organism. This report defines the prevalence of genital colonization in a large population of women, characterizes the women with S. aureus, and describes epidemiologic features of genital carriage.

Adolescent↗

Vaginal delivery in patients with a prior cesarean section.

To assess the risks and benefits of vaginal delivery in patients with prior cesarean section, the English literature on this subject from 1950 to 1980 was reviewed. The following conclusions were reached: 1) Properly conducted vaginal delivery after cesarean section is relatively safe, with a 0.7% incidence of uterine rupture, 0.93 perinatal mortality, and no maternal deaths due to uterine rupture. 2) Of those patients allowed a trial of labor, 66.7% were successfully delivered vaginally. Successful vaginal delivery occurred in 74.2% of those patients with a nonrecurrent indication for their previous cesarean section and in 33.3% of those patients whose indication for previous cesarean section was cephalopelvic disproportion. Sixty-seven percent of those patients with a prior vaginal delivery versus 47.1% of those patients without a prior vaginal delivery subsequently delivered vaginally. 3) A classic uterine scar clearly increases the probability of uterine rupture. However, the precise magnitude of the increased risk cannot be accurately determined. 4) Certain basic safety requirements such as available operating room facilities and adequate personnel for careful observation are mandatory, but other management policies that remain controversial include use of regional anesthesia, oxytocin administration, timing of hospital admission, artificial rupture of membranes, mode of delivery, proper method to evaluate the uterine scar, and delivery of fetuses in breech presentation and twins. 5) A policy of selective vaginal deliveries among patients with prior cesarean sections will result in cost reductions due to decreased postpartum hospitalization.

Cesarean Section↗

The use of amniotic fluid 3-methyl histidine to creatinine molar ratio for the diagnosis of intrauterine growth retardation.

To determine if the amniotic fluid 3-methyl histidine to creatinine molar ratio (3MH:CR) could prove useful for the antepartum detection of intrauterine growth retardation (IUGR), the 3MH:CR was determined retrospectively in 3 groups of human amniotic fluids. Group A consisted of amniotic fluids from pregnancies yielding IUGR fetuses whose birth weight was less than or equal to the tenth percentile for gestational age; group B consisted of amniotic fluid from pregnancies yielding infants whose birth weight was greater than the tenth but less than or equal to the 25th percentile for gestational age; group C consisted of amniotic fluids from pregnancies yielding infants whose birth weight was greater than the 25th but less than or equal to the 75th percentile for gestational age. The mean 3MH:CR x 10(-3) for groups A, B, and C were 15.9 +/- 1.9, 5.4 +/- 0.8, and 6.2 +/- 0.5, respectively. The mean 3MH:CR x 10(-3) was statistically different between groups A and B (P less than or equal to .001) and between groups A and C (P less than or equal to .001), but not statistically different between the 2 control groups. Employing an upper limit of normal of 8 for the 3MH:CR x 10(-3), 13 of 15 IUGR neonates were correctly identified as IUGR, and 23 of 27 neonates were correctly identified as being of normal birth weight for gestational age (sensitivity 86.7%, specificity 85.2%, incidence of correct diagnosis 85.7%). No consistent relationship was shown to exist between maternal serum and amniotic fluid 3-methyl histidine level. There was no statistically significant relationship between 3MH:CR x 10(-3) and gestational age. The comparison of the data generated in this study to that obtained with previously reported ultrasonic and biochemical techniques suggests that the amniotic fluid 3MH:CR ratio may prove helpful in establishing the antenatal diagnosis of IUGR, particularly in cases where the gestational age is uncertain.

Amniotic Fluid↗

Clinical experience with a screening program for gestational diabetes.

Screening for abnormal glucose metabolism was carried out in 2,077 pregnant women. Historical or clinical risk factors for gestational diabetes were present in 959 women (group 1). The remaining 1,118 patients composed group 2. A 50 gm oral glucose load and a 1-hour serum glucose determination with a threshold of 150 mg/dl were used as a glucose challenge screening test (GCT). Patients with an abnormal GCT underwent an oral glucose tolerance test (GTT). Group 1 patients underwent screening at the initial clinic visit or when the clinical risk factor was first recognized, with repeat screening at 28 to 32 weeks if the initial testing was normal. Group 2 patients were screened at 28 to 32 weeks. In group 1, 69 patients (7.2%) exhibited an abnormal GCT and 14 (1.5%) demonstrated an abnormal GTT. In group 2, 68 patients (6.1%) exhibited an abnormal GCT and 16 (1.4%) demonstrated an abnormal GTT. These incidences are not statistically different. The estimated costs per patient screened and per case of gestational diabetes detected were $4.75 and $328.96, respectively.

Blood Glucose↗

Propiram and codeine in episiotomy pain.

To evaluate relative efficacy, safety, and time course of analgesia, propiram fumarate (50 and 100 mg), a new narcotic agonist-antagonist, was compared with codeine sulfate (60 mg) and placebo in a clinical trial with a single peroral dose, parallel, stratified, randomized, and double-blind design involving 80 hospitalized postpartum women with medium or severe episiotomy pain. Using verbal subjective reports as index of response, patients rated pain intensity and side effects at periodic interviews for 6 h. Relative efficacy findings based on peak effects and summed pain-intensity differences suggested dose-dependent analgesia with propiram and also that 60 mg codeine lay between 50 mg propiram and placebo. Moreover, after 50 or 100 mg propiram, 8 of 20 patients reported greater than 50% reduction of initial pain compared with 7 of 20 after 60 mg codeine and 2 of 20 after placebo. After each of the propiram doses, distinct analgesia began within 1/2 h and reached peak effect between 1 h (p less than 0.02) and 2 h (p less than 0.05). After f60 mg codeine, onset was slower and peak later (4 h, p less than 0.05). All three active drugs continued to act until the 5th or 6th h. Drowsiness was the only statistically significant side effect reported after propiram. These results suggest that single 50 or 100 mg doses of propiram were effective in episiotomy pain, induced stronger analgesia than 60 mg codeine, and took effect more rapidly.

Analgesics↗

Newborn brain stem auditory evoked responses and perinatal clinical events.

The technique of brain stem auditory evoked electroencephalographic response testing was applied to 61 newborn infants in an attempt to study the potential influence of perinatal risk factors for hearing impairment and/or asphyxial brain damage. The results, althoug not conclusive, indicate that birth asphyxia and/or low birth weight may be associated with shortened latencies of evoked potentials. An efferent mechanism may account for this phenomenon.

Asphyxia Neonatorum↗

Nefopam and propoxyphene in episiotomy pain.

To evaluate relative efficacy, safety, and time course of analgesia, nefopam (45 and 90 mg), a new centrally acting nonnarcotic analgesic, was compared with propoxyphene (65 mg) and placebo in a single oral dose, parallel, stratified, randomized, double-blind trial with 100 hospitalized postpartum women with medium or severe episiotomy pain. Using subjective reports as indices of response, patients rated pain intensity and side effects at periodic interviews for 6 hr. After 45 and 90 mg nefopam, 21 of 25 and 20 of 25 patients (p less than 0.01) reported more than 50% reduction of pain, whereas after 65 mg propoxyphene 18 of 25 (p less than 0.05) and after placebo 11 of 25 reported reduction in pain. Relative efficacy, based on summed pain intensity differences, showed measurable but modest dose-dependent analgesia with nefopam, suggesting that the effectiveness of 65 mg propoxyphene lay between 45 mg nefopam and placebo. Side effects included mild dizziness and hypothermia after nefopam and mild elevation of diastolic arterial pressure after nefopam and propoxyphene. Our results suggest that 45- and 90-mg doses of nefopam induced more analgesia than 65 mg propoxyphene in the relief of episiotomy pain.

Adolescent↗

Ritodrine hydrochloride: a betamimetic agent for use in preterm labor. I. pharmacology, clinical history, administration, side effects, and safety.

Ritodrine hydrochloride has become the first drug approved in the United States specifically for use in preterm labor. The drug is a beta-sympathomimetic agent with predominant effects upon beta 2 receptors of the uterus. In this report, the pharmacology, distribution, disposition, and excretion are briefly reviewed. Recommendations for selecting patients most likely to benefit from ritodrine are given, together with the dosage and administration schedules that have been found most effective. Although this drug is not without side effects, it has been more thoroughly evaluated in prospective double-blind controlled trials than any of the other agents commonly used in preterm labor. In comparison with these agents, it seems relatively safe and the side effects are usually well tolerated. Part 2 of the paper discusses the evidence for efficacy.

Administration, Oral↗

Ritodrine hydrochloride: a betamimetic agent for use in preterm labor. II. Evidence of efficacy.

In a multicenter series of randomized prospective double-blind controlled studies, ritodrine hydrochloride was compared with either ethanol or placebo in treatment of idiopathic preterm labor. When compared with controls, there was, among offspring of ritodrine-treated mothers, a significantly reduced incidence of neonatal death and respiratory distress syndrome (P less than .05 in both comparisons) and a significantly higher proportion of infants achieving 36 weeks' gestation (P less than .05) or birth weight greater than 2500 g (P less than .05). There was also a significant improvement in gestational age at delivery (P less than .05) and in the number of days gained in utero (P less than .001) among ritodrine-treated patients as compared with controls. These results, coupled with a finding of generally acceptable side effects, have contributed to ritodrine's becoming the first drug approved for the treatment of preterm labor in the United States.

Birth Weight↗