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A study to identify the effectiveness & safety of intravenous Tramadol for the management of pain during labor in low-risk pregnant women in labor.

A Prospective, Single blinded Randomized Controlled Trial to evaluate the effectiveness of intravenous Tramadol for labor analgesia in low-risk pregnant patients in labor - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085003
Enrollment
80
Registered
2025-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Inj. Tramadol 100 mg (2 ml) slow IV injection, single dose: Inj. Tramadol 100 mg (2 ml) diluted in 10 ml normal saline intravenous slowly given over 3-5 mins, single dose for each patie

Sponsors

TATA MOTORS HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Primigravida Weight more than 50 kg Well established labor (having 3-5 contractions over a period of 10 mins) Cervical dilatation of more than 3 cm and more than 80 percent effaced Hemoglobin above 10 gm per dL

Exclusion criteria

Exclusion criteria: History of alcohol OR drug abuse OR smoking Medical disorders such as diabetes and hypertension Obstetric high-risk factors such as antepartum hemorrhage, malpresentation, fetal distress, infections Multiparous females Preterm OR IUGR babies Multifetal pregnancy Weight less than 50 kg IVF pregnancy Not giving consent Contraindications to Tramadol.

Design outcomes

Primary

MeasureTime frame
To study analgesic efficacy of intravenous Tramadol as labor analgesia using Numerical Rating Scale (NRS) scoreTimepoint: at the time of administration of drug,10 mins, 20 mins, 30 mins 1 hour, 2 hours, 3 hours, at the end of delivery

Secondary

MeasureTime frame
1.To study the effect of Tramadol on duration of labor 2.To study the presence of any fetal adverse effects by APGAR. Timepoint: 1.Start of active phase of labor, delivery of placenta 2.1 min, 5 min

Countries

India

Contacts

Public ContactAnkita Saha

Tata Motors Hospital

shipra.sarkar@tatamotors.com9031057324

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026