A COMPARATIVE STUDY BETWEEN TRAMADOL AND PETHIDINE AS A FORM OF LABOUR ANALGESIA
Anahita Pandole, Ranjit Akolekar, Nagendra Sardeshpande, Shailesh Kore, VR Ambiye
Objective : To study and compare the efficacy and safety of tramadol and pethidine as labour analgesia. Methods : A prospective study of 80 patients in active labour divided into two groups receiving either intramuscular tramadol or intramuscular pethidine was carried out from January 2001 to July 2001. The pain relief and side effects with both drugs
was studied and a subsequent comparative analysis was done.
Results : At 1, 2 and 4 hours, 50%, 77.5% and 10% of patients had more than 50% of pain relief with tramadol as compared to 17.5%, 50% and more at the end of 4 hours with pethidine. 65% of patients had sedation and 12.5% of patients had vomiting with pethidine as compared 15% and 2.5% respectively with tramadol. Six patients administered pethidine developed foetal bradycardia and poor baseline reactivity out of which 2 required caesarean delivery for persistent late decelerations.
Conclusion : Our study shows that tramadol provides good labour analgesia and is a superior analgesic as compared to pethidine and with lesser incidence of vomiting and sedation and without significant foetal adverse effects.
Labour and delivery cause pain in most patients. Nulliparous women are more likely to experience severe pain than multiparous women as reported by Melzaek.1
Pain increases maternal oxygen consumption, cardiac output and circulating catecholamine levels as noted by Schnider et al2 and causes foetal tachycardia, bradycardia or dysfunctional uterine contractions.
Various methods of pain relief have been devised ranging from non-pharmacological methods like acupuncture to pharmacological techniques like epidural analgesia.
Tramadol is a synthetic 4-phenylpiperidine analogue of codeine which can be administered orally, rectally, intramuscularly, intravenously and intrathecally resulting in modestly potent analgesia without dependence, tolerance or respiratory depression.
Pethidine is a morphine like synthetic derivative of opium with modest analgesic properties and capacity to produce dependence, sedation, mydriasis, respiratory depression, vomiting and hypotension.
MATERIAL AND METHODS
This prospective study was carried out in 80 patients between the ages of 18-35 years in the department of obstetrics and gynaecology, LTMG Hospital from January to July 2001. The gestational age ranged from 35-42 weeks. All patients were
in active labour with active labour being de.ned as cervical dilatation more than 3 cms with uterine contractions every 2-3 minutes lasting more than 30 seconds. Some patients were induced with PGE2 gel and arti.cial rupture of membranes and pitocin augmentation was used in select patients.
Patients were carefully assessed as regards history, general condition, systemic examination and obstetric evaluation was done. An admission test was performed. Patients with haemoglobin less than 8 gm%, respiratory and cardiac disease, PIH, neurological or psychiatric illness, foetal distress, moderate to thick meconium, intra-uterine foetal
death, cephalo-pelvic disproportion and those unwilling for participating in the study were excluded.
The patients were divided into 2 groups. In group
I, 40 patients were given 100 mg intramuscular tramadol at the beginning of active labour. In group
II, 40 patients were given 50 mg intramuscular pethidine at the start of active labour. In both groups, patients were monitored as regards maternal pulse, blood pressure , respiratory rate and partogram charting was done.
OBSERVATION AND RESULTS
The analgesic effect of the drugs was noted as the percentage of pain relief at 1, 2 and 4 hours and interpreted as :
1. No pain relief : Grade 0 . 0%
2. Unsatisfactory relief : Grade 1 . less than 25%
3. Satisfactory relief : Grade 2 . 25-49%
4. Good pain relief : Grade 3 . 50-75%
5. Excellent pain relief : Grade 4 . more than 75%.
Average duration of labour was considered as 8 hours for primigravidas and 5 hours for multigravidas in the .rst stage and 50 mins for primigravida and 20 minutes for multigravidas in the second stage.
The mode of delivery, one and five minute APGAR scores, and maternal and foetal side effects were noted.
The mean and standard deviation of each parameter was calculated using Epistat computer software package and the paired t test and unpaired t test were used for studying significance of changes in the variables between the same and
different groups respectively.
The significant change for qualitative data was found out by Chi-square test.
It was seen that 82.5% of patients between 18-25 years used tramadol as compared to the other group where 85% of patients used pethidine.
Table 1 shows that majority of the patients in both groups were primigravidas, 65% in the tramadol group and 62.5% in the pethidine group.
Majority users are primigravidas
According to Table 2, 92.5% of deliveries in both the groups were normal vaginal deliveries. The incidence of caesarean delivery was not signi.cantly different between both groups. The indications for caesarean delivery were deep transverse arrest and non-progress in the second stage of labour in the tramadol group (one patient each), and foetal distress (2 patients) and deep transverse arrest (one patient) in the pethidine group.
Mode of delivery
Mode of Delivery
Pethidine No. Percentage No. Percentage Normal 37 92.5 37 92.5 LSCS 2 5.0 3 7.5 Forceps 1 2.5 -- -- Total 40 100 40 100
From Table 3, it can be concluded that the average duration of .rst and second stage of labour was not significantly different between the two groups nor was there any signi.cant deviation from the average duration in multi and primigravidae.
In Table 4, it was noted that 3 neonates in both groups needed active resuscitation in the form of nasal oxygen and suction and had an APGAR score
Mode of delivery
Groups Primi Multi 1st Stage (Hours) IInd Stage (Minutes) 1st Stage (Hours) IInd Stage (Minutes) Tramadol 5.99 ± 1.30* 29.80 ± 16.08* 3.52 ± 1.25* 15.61 ± 9.94* Pethidine 6.49 ± 1.39* 29.56 ± 19.23* 4.06 ± 1.23* 12.06 ± 6.18*
These babies were observed in the transient care unit and they recovered within 24 hours. Table 5 shows that the maximum effect of tramadol was at 2 hours, gradually waning at the end of 4 hours. At 1 hour, 50% of patients had 50% or more pain relief with tramadol as compared to 17.5% of patients with pethidine. At 2 hours, 77.5% of patients had good pain relief with tramadol compared to 50% of patients with pethidine. At 4 hours, all the patients given pethidine experienced pain while 10% of patients administered tramadol still experienced good pain relief. The difference in results at all three time intervals were statistically significant.
Our study also shows that the incidence of sedation and vomiting was significantly higher with pethidine as compared with tramadol. Two patients administered pethidine, had postpartum haemorrhage which was controlled by 15 methyl PGF2 injections.
In our study, we evaluated the effects of tramadol and pethidine administered intramuscularly in carefully selected patients.
We observed that although both drugs lowered the average duration of labour, this effect was not statistically significant. Milwidsky et al3 and Husslein et al4 showed that the duration of labour was slightly shorter with pethidine as pethidine
accelerates cervical dilatation and effacement.
Viegas et al5 showed that tramadol is as effective as pethidine for pain relief in labour but has a superior safety pro.le. In our study we noted that pethidine causes signi.cantly greater nausea and vomiting as compared to tramadol.
In our study, 6 patients with a reactive admission test developed foetal bradycardia and reduced variability after administration of pethidine which was treated with intravenous fluids, left lateral position and nasal oxygen. Four patients showed improvement in their intrapartum monitoring recording while two underwent caesarean delivery for persistent late deceleration with one and .ve minute APGAR scores of 3 and 9 in one baby, and 7 and 9 in the other. The other 4 neonates had normal APGAR scores. Kariniemi et al6 have demonstrated that pethidine causes reduced foetal
In our study, we noted that the pain relief with tramadol was signi.cantly greater with tramadol than pethidine. Husslein et al4 and Viegas et al5 showed that pethidine and tramadol were equally efficacious although tramadol had lesser side
effects. Olofsson et al7 demonstrated that labour pain is not sensitive to systemically administered pethidine which causes heavy sedation with neonatal depression.
There was no significant difference in the mode of delivery between the two groups. However
Sarkar et al8 showed that the caesarean delivery rate was reduced with tramadol (17%) as compared to pethidine (25%).
Despite many anecdotal reports suggesting that pethidine provides satisfactory analgesia, the majority of prospective trials report that pethidine is at best a poor analgesic in labour.
Our study suggests that tramadol is a better analgesic than pethidine with good pain relief and without signi.cant maternal or foetal adverse effects.
Though it is said that memories of labour pain fades consistently, this does not make it any more tolerable at that moment. It is therefore only humane to attempt to relieve it and to make labour more memorable for the woman.
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