Skip to content

Comparison of low-dose and standard-dose intravenous ketorolac, given along with intravenous paracetamol, for pain relief after caesarean section: a double-blind clinical study

Low-dose versus standard-dose intravenous ketorolac as an add-on to intravenous paracetamol for postoperative analgesia after cesarean section - a randomised double blind non-inferiority trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113942
Enrollment
140
Registered
2026-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Ketorolac low dose as an add on to paracetamol for post-caesarean analgesia: Group A- low dose- IV paracetamol 1 g given at the time of skin closure and then 8 hourly up to 24 hours. IV

Sponsors

Postgraduate Institute of Medical Education and Research, Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Willing to take part in the study, Singleton pregnancy, ASA II, Scheduled elective lower segment cesarean section under spinal anaesthesia, Pfannenstiel skin incision, POG- 37 to 40 weeks

Exclusion criteria

Exclusion criteria: Refusal to give consent, History of peptic ulcer or GI bleed, allergy or contraindication to Ketorolac or paracetamol, ASA III or above, Renal or hepatic dysfunction, severe pre-eclampsia, contraindication to spinal anesthesia, chronic opioid use or analgesia dependence, emergency or unscheduled cesarean section, pre exisiting chronic pain disorder or psychiatric disease interfering with pain assessment, use of general anesthesia, failure of spinal anesthesia, intraoperative blood loss more than 1 litre.

Design outcomes

Primary

MeasureTime frame
Postoperative pain intensity will be assessed using the Numeric Rating Scale.Timepoint: at 2 hours, 4 hours, 6 hours, 12 hours, 18 hours and 24 hours post surgery

Secondary

MeasureTime frame
Total Rescue Analgesia requirementTimepoint: 24 hours;Time to first rescue analgesiaTimepoint: ;Incidence of adverse effects like nausea, vomiting, gastrointestinal side effects, renal dysfunctionTimepoint: ;Time to initiation of breastfeedingTimepoint: ;Time to first ambulationTimepoint: ;Patient satisfaction scoreTimepoint:

Countries

India

Contacts

Public ContactDr Eden Vidwisha Tamang

Postgraduate Institute of Medical Education and Research

aashicool84@gmail.com9915501844

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026