A scientific research to be conducted among women in labour to reduce labour pain using either of the two injections
- Conditions
- Pregnant womenEncounter for full-term uncomplicated delivery,
- Registration Number
- CTRI/2022/08/045029
- Brief Summary
The study will commence after obtaining IRC & IEC approval. It is a randomized controlled trial done over a period of 18 months among 152 pregnant women in spontaneous labour in the department of Obstetrics & Gynecology at IGMC&RI. This study will compare the efficacy of intravenous Paracetamol Versus Intramuscular tramadol to alleviate labour pain in pregnant women. Details of the study will be explained to the participants and informed written consent will be obtained from them.
A simple random sampling method will be used in this study to recruit the subjects. Patients are assigned to either of the two groups by balloting. Two sets of 76 opaque envelopes containing piece of paper labelled as A or B will be prepared and mixed thoroughly and placed in a box in the labor ward. An envelope will be picked up by each consecutive patient who consented and fulfilled the inclusion criteria.
Antenatal women in spontaneous labour at 3cm cervical dilatation, satisfying the inclusion criteria are recruited after obtaining consent. Visual Analogue scale (VAS) will be used to assess pain intensity.
The initial pain perception is assessed at 3 cm cervical dilatation using the VAS, then patients are randomised into two groups A and B. For patients in Group A -50 mg of tramadol will be administered intramuscularly, in the upper outer quadrant of the gluteal region. For patients in Group B, an IV infusion of 1000 mg paracetamol in 100 ml solution over 15 min using a standard gravity’ dependent IV infusion set, in which each 16 drops give 1 ml (infusion rate about 130 drops/min) will be administered . The severity of labour pain will be assessed subsequently at 1 hour, 3 hours and 5 hours after drug administration, in both groups using VAS and the score is recorded in number grading scale.
The progression of labour will be monitored using WHO Partogram and standard institutional protocol will be followed for conducting delivery. A second or rescue dose will be administered for patients in both the groups after 5 hours of initial drug administration, if pain relief is inadequate, that is, a numerical rating of 6 and above on VAS, and this is recorded.
The expected outcome is that intravenous Paracetamol is expected to have better analgesic efficacy, shorter duration of labour and fewer side-effects, when compared to intramuscular Tramadol, during labour. Hence in low resource settings, intravenous Paracetamol maybe used to provide labour analgesia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 152
Antenatal women in labour with cervical dilatation 3cm Term gestation Spontaneous onset of labour Singleton pregnancy with vertex presentation.
- Women with cephalopelvic disproportion Previously scarred uterus (post myomectomy, post cesarean) History of any drug allergy Medical disorders complicating pregnancy like severe anemia, gestational diabetes mellitus, cardiac disease, pregnancy induced hypertension, pre-existing liver disorders, seizure disorders.
- Non-reassuring NST Intrauterine growth restriction (IUGR) Intrauterine foetal death Patients on antidepressants (e.g. SSRI) Patients who are not willing to participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain relief as noted in the visual analogue score baseline, 1 h, 3 hrs and 5 hrs drug administration
- Secondary Outcome Measures
Name Time Method Interval between drug administration and delivery time of delivery
Trial Locations
- Locations (1)
Indira Gandhi Medical College and Research Institute in the Department of Obg in Labour ward
🇮🇳Pondicherry, PONDICHERRY, India
Indira Gandhi Medical College and Research Institute in the Department of Obg in Labour ward🇮🇳Pondicherry, PONDICHERRY, IndiaElamathi TPrincipal investigator9003952684elamathiteva@gmail.com