Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial

Study Overview
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Brief Summary
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Tramadol for labor analgesia: a low risk placebo controlled randomised control trial

Detailed Description
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Investigators will administer 100mg tramadol or 2ml distilled water through intramuscular route in a blinded manner. Visual analogue score will be assessed in the beginning and every hour till four hours. patient satisfaction, safety outcomes, duration of 1st and 2nd stage of labor, proportion of women experiencing nausea, vomiting and increased sleepiness, postpartum haemorrhage,apgar score at 5 minute, need for nicu admission wiil be assessed at the end

Official Title
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Tramadol for Labor Analgesia in Low Risk Women: A Placebo Controlled Randomized Trial

Conditions
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Tramadol for Labor Analgesia

Intervention / Treatment
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* Drug: Tramadol Hydrochloride
* Drug: Distilled Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: delivering for first time(nulliparous) well established labor ( 3 or more contractions in a span of ten minutes cervical dilation of 4 cm or more >= 80% effacement of cervix Exclusion Criteria: any medical disorder- diabetes,hypertension obstetric high risk factors
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tramadol<br>50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic | Drug: Tramadol Hydrochloride<br>* 50mg intramuscularly<br>|
| Placebo Comparator: distilled water<br>2ml distilled water intramuscularly will be used as a placebo. | Drug: Distilled Water<br>* 2ml intramuscularly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale | visual analogue scale i.e scaling of severity of pain from 1 being mildest and 10 being most severe will be assessed at 2nd hour of administration | at 2nd hour of administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | scale of 1-5 including highly satisfied, moderately satisfied ,it is ok ,not satisfied ,highly unsatisfied | at the end of labor( within 12 hours) | 
| fetal distress | fetal tachycardia (heart rate more than 160) or fetal bradycardia (heart rate less than 100) | during labor | 
| duration of 1st and 2nd stage of labor |  | 1st and 2nd stage | 
| women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness | increased risk of postpartum haemorrhage, nausea , vomiting and sleepiness may be associated with use of tramadol | till the end of labor | 
| neonatal safety in terms of apgar score and nicu admission |  | apgar score at 0 and 5 min | 
| need for caesarean section or instrumental delivery | emergency caesarean section or need for forceps or vacuum application | during labor |