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Biomedical subjects

F Reynolds

Publications and source records attributed to F Reynolds.

At least 19 recordsLinked to original sources
PubMed1998

Effect of epidural fentanyl on neonatal respiration.

BACKGROUND: The addition of opioids to epidural infusions for laboring mothers may reintroduce the problem of neonatal depression seen with systemic opioids. The authors studied neonatal respiration and neurobehavior in newborns of mothers randomized to receive epidural analgesia with or without fentanyl. METHODS: One hundred thirty-eight women in labor received loading doses of plain bupivacaine. When pain-free, they received an infusion of either 0.125% bupivacaine alone or 0.0625% bupivacaine with 2.5 microg/ml fentanyl. After delivery, transcutaneous oxygen tension and carbon dioxide tension were recorded in the newborns every 10 s until 90 min after delivery using a transcutaneous oxygen-carbon dioxide monitor. Umbilical venous and arterial acid-base status, Apgar scores, and Neurologic and Adaptive Capacity Scores 2 h and 24 h after delivery were measured. The umbilical venous plasma fentanyl concentration was correlated with indices of neonatal respiration and welfare in the fentanyl group. RESULTS: One hundred fourteen newborns delivered vaginally were studied. In the fentanyl group, the mean (range) maternal dose of fentanyl was 184 microg (range, 53-400), and the umbilical venous fentanyl concentration was 0.077 ng/ml (range, <0.021 to 0.244). There were no significant differences between the groups for any indices of neonatal respiration or neonatal welfare, and the plasma fentanyl concentration did not correlate with any of these indices. CONCLUSIONS: The results suggest that fentanyl added to epidural bupivacaine infusions during labor does not depress neonatal respiration or adversely affect neurobehavioral scores and other indices of neonatal welfare.

Adult↗
PubMed1998

Patch tests versus use tests in skin irritation risk assessment.

In the risk assessment of the ability of a substance or preparation to cause skin irritation, a patch test involving human volunteers is often seen as providing definitive information. However, the skin exposure conditions found in an occluded patch may be far removed from those in a particular use situation, not least for such reasons as the high dose per unit area, the duration of exposure and the maceration of the skin. Whilst these factors may enhance sensitivity in the identification of intrinsic hazard, they may do little to ensure accurate safety evaluation for real use. In this paper, we report data from a series of studies with an unmarketed facial skin cosmetic product. Whilst the product was unexpectedly highly irritating in a standard patch test in 30 volunteers, subsequent use tests, including a 6x daily open application to the elbow for 3 weeks and 2x daily application in a half-face test lasting 3 to 4 weeks and involving 52 volunteers failed to show any evidence of skin irritation. It is concluded that the most meaningful results for skin irritation risk assessment are likely to come from studies which involve relevant patterns of exposure.

Adult↗
PubMed1997

Neonatal welfare and placental transfer of fentanyl and bupivacaine during ambulatory combined spinal epidural analgesia for labour.

To investigate current concerns that potent opioid drugs, such as fentanyl, used for labour regional analgesia may affect neonatal status, maternal and umbilical plasma concentrations of fentanyl and bupivacaine at delivery were measured in 40 nulliparous patients receiving low-dose combined spinal epidural analgesia. Neonatal assessments included Apgar scores, umbilical blood gases and neurobehavioural tests. All maternal and umbilical venous plasma concentrations were low. Maternal and umbilical vein total fentanyl concentrations increased with increasing doses of epidural fentanyl (r = 0.46 and 0.30, respectively, p < 0.01). There were no significant differences between maternal and umbilical venous plasma total or free concentrations of fentanyl. Mean umbilical vein/maternal fentanyl ratios were 1.12 for total drug and 1.20 for free drug and values were unrelated to the last epidural bolus to delivery interval (r = 0.12, p = 0.49). There were no correlations between Apgar scores, umbilical blood gases or neurobehavioural scores and umbilical venous concentrations of either fentanyl or bupivacaine. The dose of fentanyl used for ambulatory combined spinal epidural analgesia would appear to have a negligible effect on neonatal condition.

Ambulatory Care↗
PubMed1997

The influence of epidural administration of fentanyl infusion on gastric emptying in labour.

The effect of epidural infusions containing fentanyl on maternal gastric emptying in labour was examined using the rate of paracetamol absorption. Women were randomly allocated to receive one of two epidural infusions, bupivacaine 0.125% alone or bupivacaine 0.0625% with fentanyl 2.5 micrograms.ml-1 at a rate of 10-12 ml.h-1. Paracetamol 1.5 g was given orally to women after either 30 ml of the infusion solution had been given (mean time 2.5 h, study A) or 40-50 ml (mean time 4.5 h. study B). Six venous blood samples were taken over the next 90 min for measurement of plasma paracetamol concentration. There were no significant differences in maximum plasma paracetamol concentration, time to maximum paracetamol concentration and area under the concentration-time curve between the two groups for study A. In study B the time to maximum plasma paracetamol concentration was significantly delayed in women receiving > 100 micrograms fentanyl compared with controls (p < 0.05). We conclude that the dose of fentanyl that may delay gastric emptying when given by epidural infusion is greater than 100 micrograms.

Acetaminophen↗
PubMed1997

Visual assessment of human skin irritation: a sensitive and reproducible tool.

Human volunteer studies of skin irritation have been carried out for decades, both for research and for safety evaluation purposes. For the majority of this time, and consequently for the majority of the studies, assessment of the skin reactions has been made visually. Typical endpoints include erythema, oedema, dryness and scaling, some or all of which would be rated on a simple scale, eg 0, +/-, +, ++, + + +. Such approaches can be criticized as subjective, of poor reproducibility, lacking in sensitivity and highly variable between observers and/or institutions. In consequence, instrumental methods of assessment have been strongly promoted and do indeed offer several advantages, not least their objectivity. However, it is possible to use the human eye, which is a very sensitive tool, to make detailed, accurate and reproducible descriptions of skin irritation reactions. To achieve this, it is necessary to give prolonged and thorough training to each observer. In this paper, 3 examples of human volunteer studies, in which different pairs of trained observers independently carried out double blinded scoring of the irritation reactions, are reported. The grading patterns produced were almost identical; statistical analysis showed that properly trained observers are in fact able to reliably measure a grade of erythema to within +/- 1 on a 10 point scale; 97.6% of scores were within 2 grade points on this scale. These results provide evidence that visual scoring can be sensitive, reliable and reproducible within a testing institution.

Dermatitis, Irritant↗
PubMed1996

Long term backache after childbirth: prospective search for causative factors.

OBJECTIVES: To assess in a prospective randomised study the association between motor block resulting from high and low dose epidural infusions of bupivacaine in labour and the incidence of long term backache after childbirth, and to compare the incidence of backache in women not receiving epidural analgesia. DESIGN: Women requesting epidural analgesia in labour between October 1991 and March 1994 were randomised to receive infusions of either bupivacaine alone or low dose bupivacaine with opioid. Data were collected during labour and the immediate postpartum period from these women and from women recruited at random over the same time from those who had laboured without epidural analgesia. A postal questionnaire about symptoms was sent three months after childbirth to all women. Further data were collected one year after childbirth from those who had reported new backache at three months. SETTING: St Thomas's Hospital, London. SUBJECTS: 599 women were recruited, of whom 450 (75%) replied to a follow up questionnaire. RESULTS: 152 women (33.8% of responders) reported backache lasting three months after delivery and, of these, 33 (7.3%) had not previously suffered with backache. There were no significant differences between the treatment groups in the incidence of postnatal backache overall or of new backache or any symptoms after childbirth. Among all demographic, obstetric, and epidural variables examined the only factors significantly associated with backache after childbirth were backache before and during pregnancy. CONCLUSIONS: The incidence of new long term backache was not significantly increased in women who received epidural analgesia in labour. Motor block resulting from epidural local anaesthetic administration was not a significant factor in the development of backache.

Adult↗
PubMed1996

A double-blind comparison of 0.25% ropivacaine and 0.25% bupivacaine for extradural analgesia in labour.

Ropivacaine is a new aminoamide local anaesthetic. Compared with bupivacaine, ropivacaine possesses a higher threshold for systemic toxicity and a high selectivity for sensory fibres. We have compared prospectively these two agents in a concentration of 0.25% for extradural analgesia in labour. A total of 104 parturients requesting extradural analgesia were randomized to receive either ropivacaine or bupivacaine. The women in the bupivacaine group required more top-up doses to maintain analgesia (median 3.0 vs 2.0) (P < 0.05). The onset of sensory block, quality of analgesia, ultimate level of maximum sensory block and maternal satisfaction were similar in both groups. The incidence, intensity and duration of motor block were slightly but not significantly less in the ropivacaine group. The ropivacaine group had a higher incidence of spontaneous vaginal delivery (70.59% vs 52.00%). There was no significant difference in neonatal outcome as assessed by Apgar scores, umbilical acid-base status and neurological and adaptive capacity score at 2 and 24 h after delivery. We conclude that ropivacaine and bupivacaine in a concentration of 0.25% produced comparable analgesia for pain relief of labour with no detectable adverse effect on the neonate.

Adolescent↗
PubMed1996

Epidural infusion of low-dose bupivacaine and opioid in labour. Does reducing motor block increase the spontaneous delivery rate?

Labouring women were randomly allocated to receive epidural infusions during labour of either 0.125% plain bupivacaine (n = 200) or a combination of 0.0625% bupivacaine with either 2.5 micrograms.ml-1 fentanyl or 0.25 micrograms.ml-1 sufentanil (n = 199) each starting at 12 ml.h-1 and adjusted as necessary to maintain analgesia. The dose of bupivacaine, both hourly (p < 0.001) and total (p < 0.001), was significantly lower in the group receiving the combination. Motor block was significantly less common and less severe in the combination group (p < 0.001). These reductions did not result in a significant increase in spontaneous deliveries. Maternal satisfaction with first (p < 0.001) and second stage analgesia (p < 0.001) was significantly increased in the combination group. The addition of opioid to the epidural infusion did not reduce the incidence of perineal pain. There were no significant differences between the groups in neonatal outcome or the incidence of early postnatal symptoms.

Adult↗
PubMed1996

The effect of epidural opioids on maternal oxygenation during labour and delivery.

The effects of epidural fentanyl on the incidence of maternal hypoxaemia during labour and on neonatal welfare were examined. Women were randomly allocated to receive one of two epidural infusions, bupivacaine 0.125% alone or bupivacaine 0.0625% with 2.5 micrograms.ml-1 fentanyl, and maternal arterial oxygen saturation was monitored continuously until delivery. The median incidence of desaturation (SpO2 < 95%) during the active phase of the second stage of labour was significantly greater in the fentanyl group than in controls (2.9 versus 0.6 min.h-1, p = 0.02). Similarly, the incidence of desaturation to SpO2 < or = 90% was greater in the fentanyl group than in controls (p = 0.02). There was no correlation between maternal oxygenation or plasma fentanyl concentration and neonatal welfare as measured by umbilical arterial and venous blood gas and acid base status, Apgar score and Neurologic and Adaptive Capacity Score.

Adolescent↗
PubMed1996

Sciatic nerve palsy following childbirth.

Two cases are reported of sciatic nerve palsy after delivery by Caesarean section in primigravidae. One mother was slender and had an emergency Caesarean section for failure to progress with a breech presentation. Epidural analgesia during labour was extended for operative delivery. The other mother was obese, mildly hypertensive, had a large baby with a high head and was delivered by elective Caesarean section under epidural anaesthesia. She experienced severe intrapartum hypotension. Both patients suffered right sided sciatic nerve palsy. The aetiologies of obstetric palsies and those following regional block are reviewed and the importance of careful diagnosis and of avoiding peripheral nerve compression during regional block are emphasised.

Adult↗