Tramadol for Labor Analgesia
Conditions
Brief summary
Tramadol for labor analgesia: a low risk placebo controlled randomised control trial
Detailed description
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
Interventions
DRUGTramadol Hydrochloride
50mg intramuscularly
DRUGDistilled Water
2ml intramuscularly
Sponsors
Maulana Azad Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue scale | at 2nd hour of administration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fetal distress | during labor | fetal tachycardia (heart rate more than 160) or fetal bradycardia (heart rate less than 100) |
| duration of 1st and 2nd stage of labor | 1st and 2nd stage | — |
| patient satisfaction | at the end of labor( within 12 hours) | scale of 1-5 including highly satisfied, moderately satisfied ,it is ok ,not satisfied ,highly unsatisfied |
| neonatal safety in terms of apgar score and nicu admission | apgar score at 0 and 5 min | — |
| need for caesarean section or instrumental delivery | during labor | emergency caesarean section or need for forceps or vacuum application |
| women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness | till the end of labor | increased risk of postpartum haemorrhage, nausea , vomiting and sleepiness may be associated with use of tramadol |
Contacts
Primary Contactdr aastha raheja
Backup Contactdr krishna agarwal
Outcome results
None listed