Comparison of the effectiveness of intramuscular injection of Ketorolac with PCA pump Containing Morphine and Apotel in Pain control of Patients after Cesarean Section

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

IRCT

Registry ID

IRCT20231005059625N1

Enrollment

Registered

2023-10-25

Start date

2023-11-22

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

Painlessness after surgery.

Interventions

Intervention 1: Intervention group1: Intervention Group: In the intervention group, an Optofuser analgesia pump from Darman Gostar Sepano in Iran was used. This pump had a capacity of 100 cc and opera

Eligibility

Sex/Gender

Female

Age

20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnant mothers, 20-40 years old, Elective caesarean section with transverse incision Pregnancy age at least 37 weeks American Society of Anesthesiology based on II and I ASA class

Exclusion criteria

Exclusion criteria: Suffering from gestational hypertension Receiving NSAID and narcotics before surgery Mothers of macrosomic and multiple babies Spinal or epidural anesthesia method history of peptic ulcer history of coagulation disorders BMI more than 30

Design outcomes

Primary

Measure	Time frame
Determination and comparison of the average pain intensity of the patients after the cesarean section in the group receiving intramuscular ketorolac and the group receiving morphine and Apotel by PCA pump. Timepoint: , 15 minutes after the operation (before intervention for analgesia) and 6, 12 and 24 hours after the cesarean section. Method of measurement: Visual pain score(Visual Analogue Scale).	—

Measure

Time frame

Determination and comparison of the average pain intensity of the patients after the cesarean section in the group receiving intramuscular ketorolac and the group receiving morphine and Apotel by PCA pump. Timepoint: , 15 minutes after the operation (before intervention for analgesia) and 6, 12 and 24 hours after the cesarean section. Method of measurement: Visual pain score(Visual Analogue Scale).

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Secondary

Measure	Time frame
The mean of hemodynamic indices (average blood pressure, heart rate and SPO2). Timepoint: 15 minutes after the operation (before intervention for analgesia) and 6, 12 and 24 hours after the operation. Method of measurement: Automatic monitoring device.;Frequency distribution of mothers' need to receive an additional dose of anesthesia. Timepoint: In the first 24 hours after the operation. Method of measurement: Based on the history of the patient.;Frequency distribution of side effects (nausea, vomiting, abnormal sleepiness, respiratory depression, stomach pain). Timepoint: In the first 24 hours after the operation. Method of measurement: Based on the history of the patient.	—

Measure

Time frame

The mean of hemodynamic indices (average blood pressure, heart rate and SPO2). Timepoint: 15 minutes after the operation (before intervention for analgesia) and 6, 12 and 24 hours after the operation. Method of measurement: Automatic monitoring device.;Frequency distribution of mothers' need to receive an additional dose of anesthesia. Timepoint: In the first 24 hours after the operation. Method of measurement: Based on the history of the patient.;Frequency distribution of side effects (nausea, vomiting, abnormal sleepiness, respiratory depression, stomach pain). Timepoint: In the first 24 hours after the operation. Method of measurement: Based on the history of the patient.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMersede Faghihshojaei

Birjand University of Medical Sciences

m.faghihshojaei@gmail.com+98 56 3238 5000

Outcome results

None listed

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