Tramadol versus placebo for labor analgesia in low risk women: a randomized controlled trial
DOI:
https://doi.org/10.18203/2320-1770.ijrcog20196045Keywords:
Labor analgesia, Pain relief, Tramadol, Visual analogue scoreAbstract
Background: In low- and middle-income countries epidural analgesia is generally not available and practically no form of labor analgesia is given to the majority of the parturient. The purpose of study was to evaluate the safety and efficacy of tramadol as a labor analgesic during first stage of labor.
Methods: Pregnant women admitted in the labor room satisfying the eligibility criteria were randomized to receive intramuscular injection of either 100 mg tramadol or 2 ml distilled water. Visual analogue score (VAS) was assessed at the beginning and every hour till 4 hours. Pain satisfaction, duration of second stage of labor, fetal heart rate, mode of delivery, and any maternal side effects of the study drug were recorded. Neonatal evaluation using Apgar score at 1 and 5 minutes was done. For statistical analysis Student t-test, Chi Square test and Fisher’s exact test were used.
Results: Total of 86 women were included in the study. The VAS scores were significantly lower in the tramadol group at 1, 2 and 3 hours after the administration. Pain relief satisfaction was significantly higher in the tramadol group. Rate of cervical dilatation, duration of the second and the third stage, need for instrumental delivery or lower segment caesarean section, rate of fetal distress and Apgar score at one and five minutes were comparable in both the groups. Nausea was significantly higher in tramadol group.
Conclusions: Tramadol is a safe and efficacious drug which is inexpensive, easily available and easy to administer with few minor side effects. It can be used as a labour analgesic as an alternative to epidural analgesia in settings where epidural analgesia is not available. Trial registration: Clinicaltrials.gov PRS registration number: NCT02999594.
References
Elbohoty AE, Abd-Elrazek H, Abd-El-Gawad M, Salama F, El-Shorbagy M, Abd-El-Maeboud KH. Intravenous infusion of paracetamol versus intravenous pethidine as an intrapartum analgesic in the first stage of labor. Int J Gynaecol Obstet. 2012;118:7-10.
Khooshideh M. A comparison of tramadol and pethidine analgesia on the duration of labour: A randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009;49:59-63.
Simkin P, Dickersin K. Control of pain in labor. In: Enkin M, Keire MJNC, Renfrew M, Neilson JA, editors. A guide to effective care in pregnancy and childbirth: United Kingdom: Oxford University Press; 1996:247-61.
Pandya ST. Labour analgesia: recent advances. Indian J Anaesth. 2010;54:400.
Viegas O, Khaw B, Ratnam S. Tramadol in labour pain in primiparous patients. A prospective comparative clinical trial. Eur J Obstet Gynecol Reprod Biol. 1993;49:131-5.
Ullman R, Smith LA, Burns E, Mori R, Dowswell T. Parenteral opioids for maternal pain management in labour. Cochrane Library. 2010:9.
Kale T, Kamble S. A prospective study of effect of intramuscular tramadol in labor analgesia. Int J App Basic Med Res. 2015;5:87-91.
Rani MS, Prasad KV. Comparative study of efficacy of tramadol as an analgesic in labor on primigravida and mutligravida. Int J Pharma Res Rev. 2015;3:2347-50.
Hema M, Ramappa R, Sandesh M, Akash B. Intravenous paracetamol infusion versus intramuscular tramadol as an intrapartum labor analgesic. Int J Reprod Contracept Obstet Gynecol. 2015;4:1726-9.
Chandnani K. Sainee HB. Pain relief in labour: tramadol versus pentazocine. Int J Reprod Contracept Obstet Gynecol. 2013;2:186-18.
Patil S, Somashekara SC, Veerabhadra GK, Bhanurekha G, Jayanthi R, Deepalaxmi S. Tramadol analgesia in labor. Int J Pharm Biomed Res. 2012;3:49-51.
Khustagi, Surpaneni N. A thought for tramadol hydrochloride as labor analgesic. Anaes Essays Res. 2012;6:147-50.
Kaur Makkar J, Jain K, Bhatia N, Jain V, Mal Mithrawal S. Comparison of analgesic efficacy of paracetamol and tramadol for pain relief in active labor. J Clin Anesth. 2015;27:159-63.
Lallar M, Anam H, Nandal R, Singh SP, Katyal S. Intravenous paracetamol infusion versus intramuscular Tramadol as an intrapartum labor analgesic. J Obstet Gynaecol India. 2015;65:17-22.