الفهرس 
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Abstract
Labor pain includes components that differ completely from pain in general. It is the result of natural events and has a special meaning, leading in most cases to something extremely positive, the birth of a healthy child. Labor is a painful condition, considered to be one of the most intense and stressful experiences especially for nulliparous women. Although studies have found significant rise in pain threshold during labor. It is nonetheless an important goal to provide safe and effective methods of analgesia for women in a pain in order, amongst other reasons, to obtain her maximum cooperation.
The most effective non-invasive pharmacological intervention is through the use of opioids or tramadol injection through an epidural catheter. Other effective interventions include combined spinal/epidural analgesia, low-dose epidural analgesia, as well as, patient controlled analgesia.
Those pharmacological techniques despite being effective yet require participation of an expert anesthesiologist, costly equipment and continuous maternal and fetal electronic monitoring tools, which are not readily available in all obstetric units, particularly in developing countries.
In general, there are two primary types of analgesic agents: opioids and non-opioids. Opioids include morphine, codeine and pethidine. Non- opioids analgesics have antipyretic and analgesic properties. They don not bind to opioids receptors and are, therefore, milder forms of painkiller. Non-opioid analgesics include acetaminophen (paracetamol) and non-steroidal anti-inflammatory drugs (NSAIDS).
Non-opioids analgesics differ from opioid analgesics in number of points. First, they are weaker painkillers; they are more suitable for mild or moderate pain. Second, they have a ceiling effect (i.e. a maximum dose that can control pain; increasing the dose beyond which would not offer further analgesia). Third, they do not produce tolerance or physical dependence.
Nevertheless, two major concerns are associated with the use of opioid analgesia. First is the risk of fetal/neonatal respiratory depression. Second is the cost and availability.
The aim of this study is to evaluate the efficacy and adverse effects of oral paracetamol (500mg) during the active phase of labor compared with oral solpadeine (paracetamol 500mg with codeine 8mg) as a method for intrapartum analgesia in a sample of gravid women delivering at Ain Shams University Maternity Hospital in a sample of gravid women delivering at Ain Shams University Maternity Hospital.
A total of 220 gravid women during the interval between February and June 2017 were recruited in the current randomized controlled trial. The study included gravid women in singleton term pregnancy. Women with malpresentation, had high risk pregnancy, had been maintain on chronic anti-inflammatory treatment and those had hypersensitivity to codeine or paracetamol were excluded from the trial.
Concealed random allocation was adopted. Women of the first group received oral paracetamol capsule contain 500mg paracetamol at beginning of the active phase of labor. A Second dose was given after 4 hours if needed. The second group received oral Solpadeine capsule contains paracetamol 500mg and codeine 8mg, at the beginning of the active phase of labor. Repeat doses were given upon woman’s request (with maximum dose 24mg, at least 2 hours before expected time of delivery which roughly corresponding to a cervical dilatation of 8 cm).
The primary outcome was the labor pain perception. Labor pain perception was assessed using the semi- objective visual analogue scale (VAS) with 0 denoting no pain and 10 denoting the worst pain. Labor pain perception was assessed initially (before administration of the allocated drug) and then 1 hour, 2 hours, 3 hours and 4 hours after administration of the drug.
Secondary outcomes included maternal and neonatal outcomes. Maternal outcomes included need further analgesia, nausea/vomiting, dizziness and satisfaction. Neonatal outcomes included 1 and 5-min Apgar scores, need for additional measures for neonatal resuscitation and the rate of respiratory depression.
The result shows that there were no significant differences in all the sociodemographic data in both group as the mean age of included women was 29.3±3.9 years (range: 20-39 years), the mean BMI was 29.4±1.4 and the mean gestational age was 39.5±0.9 weeks (range: 37 – 42 weeks).
Pain score significantly decreased from basal level in both groups from hour-1 to hour-2 as in solpadeine group at hour 1 (66.3mm) and hour 2 (59.1mm) and in paracetamol group hour 1 was (74.0mm) and hour 2 (68.9mm). pain was significantly lower in solpadeine group after treatment at hour-2 (59.1mm).
The mean number of doses needed in the solpadeine group is 2.3±0.7 doses which needed from one dose of solpadeine to 3 doses; On the contrary the mean number of doses needed in the paracetamol group is 2.9±0.5 doses which needed from two doses of paracetamol to 3.5 doses of it and this mean that Number of doses was not significantly lower among solpadeine group than among paracetamol group.
Regarding the course of labor, the current study showed no significant differences between women of both groups regarding the course of labor, in terms of the mode of delivery and the duration of the first or second stages of labor.
Regarding the maternal safety and adverse effects the current trial showed that administration of codeine was significantly associated with almost 2-fold and 4-fold higher rates of maternal dizziness and nausea, vomiting abdominal pain, indigestion and disorientation when compared to paracetamol.
Regarding the neonatal outcome, APGAR 1 <7.0 was significantly lower among solpadeine group than among paracetamol group. No significant difference between solpadeine and paracetamol groups regarding APGAR5, fetal resuscitation and NICU admission.