Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy

Cairo University (CU)

Status: Completed

Conditions: Postoperative Pain; Hysterectomy

Treatments: Drug: Ketorolac Injectable Solution; Drug: Ibuprofen 800 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05610384

MD-246-2022

Details and patient eligibility

About

The aim of this study is to compare the analgesic effect of intravenous ibuprofen to ketorolac for pain control after open hysterectomy

Full description

Thirty minutes before the surgery, all patients will receive 1 gm paracetamol intravenously then every 6 hours postoperatively.

A research assistant is responsible for opening the envelopes, group assignment and drug preparation (the three doses will be prepared and marked with the patient's name as well as the time of administration) without any further involvement in the study. The patient, attending anesthetist, nurse and data collector will be blinded to the administered drug.

Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 8 mg dexamethasone drugs.

Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 1 mcg/kg fentanyl, and tracheal intubation will be facilitated by 0.5 mg/kg atracurium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg atracurium every 20 minutes. Intraoperative analgesia will be in the form of 1 mcg/kg fentanyl boluses as needed.

Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 2, 4, 6, 10, 18, and 24 h after leaving the operating room. If the VAS score is > 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted.

Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting

Enrollment: 100 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult (40-65 years)
• ASA I-II women
• scheduled to undergo open elective abdominal hysterectomy with or without salpingo-oophorectomy

Exclusion criteria

• renal impairment,
• allergy to any of study's drugs,
• history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease,
• severe cardiac comorbidity (impaired contractility with ejection fraction < 50%, heart block, significant arrhythmias, tight valvular lesions),
• patients undergoing surgery for suspected gynaecological cancer,
• patients on chronic analgesic medication,
• inability to comprehend the Visual Analogue Pain Scoring Scale

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Ketorolac group

Active Comparator group

Description:

ketorolac 30 mg

Treatment:

Drug: Ketorolac Injectable Solution

Ibuprofen group

Active Comparator group

Description:

ibuprofen 800 mg

Treatment:

Drug: Ibuprofen 800 mg