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Tramadol for labor analgesia: a low risk placebo controlled randomised control trial
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tramadol | Experimental | 50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic |
|
| distilled water | Placebo Comparator | 2ml distilled water intramuscularly will be used as a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol Hydrochloride | Drug | 50mg intramuscularly |
| |
| Distilled Water |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| dr aastha raheja | Contact | 8586032882 | aastha_raheja2000@yahoo.com | |
| dr krishna agarwal | Contact | 9871214208 | drkrishna.agarwal@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| dr aastha raheja | Maulana Azad Medical College | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 23, 2018 | |
| Reset | Oct 24, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 23, 2018 | Oct 24, 2018 |
| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Drug |
2ml intramuscularly |
|
| 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 |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |