A clinical trial to study the effects of two drugs, diclofenac sodium and paracetamol for pain relief following childbirth.

Comparison of rectal diclofenac sodium with oral paracetamol for pain relief following Instrumental vaginal delivery-A Randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/05/008521

Enrollment

262

Registered

2017-05-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: O909- Complication of the puerperium, unspecified Health Condition 2: null- Pain relief in Instrumental vaginal delivery

Interventions

Intervention1: Rectal Diclofenac sodium and oral placebo: Diclofenac sodium rectal suppository 50 mg BD and oral placebo TDS till 48 hours after delivery Control Intervention1: Oral Paracetamol and re

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women with singleton pregnancy at term aged more than 18 years undergoing Instrumental vaginal delivery

Exclusion criteria

Exclusion criteria: 1.History of sensitivity to Non-steroidal anti-inflammatory drugs 2.Severe preeclampsia 3.Peptic ulcer disease 4.History of bronchial asthma 5.Known case of liver and renal disease 6.Complete perineal tear 7.Fetal malpresentations 8.Preterm birth and low birth weight 9.Multiple pregnancy 10.Major postpartum haemorrhage( >1000 ml blood loss) 11.Use of epidural analgesia

Design outcomes

Primary

Measure	Time frame
Pain relief after Instrumental vaginal delivery by using Visual analogue scaleTimepoint: Visual analogue scale at 24 and 48 hours after delivery with minimum expected difference of 0.8 in the pain score between the group as an impact of intervention	—

Secondary

Measure	Time frame
Not applicableTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactDr Vishnupriya C

Jawaharlal Institute of Postgraduate Medical Education and Research

dilipkm2@gmail.com9442136037

Outcome results

None listed

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