Comparison of paracetamol-ketrolac infusion pump analgesia compared to diclofenac suppositories

Comparison of paracetamol-ketrolac infusion pump analgesia versus diclofenac suppository after cesarean section under spinal anesthesia: a double-blind clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220706055402N4

Enrollment

118

Registered

2023-10-14

Start date

2023-09-22

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Cesarean section under spinal anesthesia.

Interventions

Intervention group: One group of patients received two suppositories of diclofenac 100 mg (aburaihan pharma.co.tehran-iran) every 8 hours and the second group was given a patient-controlled analgesia

Eligibility

Sex/Gender

All

Age

18 Years to 38 Years

Inclusion criteria

Inclusion criteria: Full pregnancy Age 18 to 38 years Elective cesarean delivery Primary or repeated caesarean section Undergoing spinal anesthesia

Exclusion criteria

Exclusion criteria: Drug use Bleeding disorders Severe mental disorders History of allergy to studied drugs Severe obesity (BMI above 35) Conversion of spinal anesthesia to another method of anesthesia Preeclampsia and complications during surgery

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: The patient's evaluation will be done by a doctor who is not aware of the groups, at time zero, 1 hour later, 6, 12 and 24 hours later. Method of measurement: Visual Analogue Scale.	—

Secondary

Measure	Time frame
SPO2. Timepoint: The patient's evaluation will be done by a doctor who is not aware of the groups, at time zero, 1 hour later, 6, 12 and 24 hours later. Method of measurement: Reading from the monitoring device.;Mean Arterial pressure (MAP). Timepoint: At time zero, 1 Hour later, 6, 12 And 24 Hours later. Method of measurement: Reading from the monitoring device.;Pulse Rate (PR). Timepoint: At time zero, 1 Hour later, 6, 12 And 24 Hours later. Method of measurement: Pulse oximetry.;Patient satisfaction. Timepoint: At time zero, 1 Hour later, 6, 12 And 24 Hours later. Method of measurement: 5-point Likert scale.;Request for housing. Timepoint: The first housing request time and the total amount of additional housing consumed in 24 hours are calculated and recorded. Method of measurement: Based on prescription for patients, indomethacin 100 mg suppositories (aburaihan pharma.co-iran).	—

Measure

Time frame

SPO2. Timepoint: The patient's evaluation will be done by a doctor who is not aware of the groups, at time zero, 1 hour later, 6, 12 and 24 hours later. Method of measurement: Reading from the monitoring device.;Mean Arterial pressure (MAP). Timepoint: At time zero, 1 Hour later, 6, 12 And 24 Hours later. Method of measurement: Reading from the monitoring device.;Pulse Rate (PR). Timepoint: At time zero, 1 Hour later, 6, 12 And 24 Hours later. Method of measurement: Pulse oximetry.;Patient satisfaction. Timepoint: At time zero, 1 Hour later, 6, 12 And 24 Hours later. Method of measurement: 5-point Likert scale.;Request for housing. Timepoint: The first housing request time and the total amount of additional housing consumed in 24 hours are calculated and recorded. Method of measurement: Based on prescription for patients, indomethacin 100 mg suppositories (aburaihan pharma.co-iran).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Moftakhar

Ahvaz University of Medical Sciences

moftakhar-f@ajums.ac.ir+98 61 3338 3372

Outcome results

None listed

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