Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy

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

Detailed Description
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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

Official Title
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Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy: a Randomized Controlled Trial

Conditions
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Postoperative Pain, Hysterectomy

Intervention / Treatment
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* Drug: Ketorolac Injectable Solution
* Drug: Ibuprofen 800 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketorolac group<br>ketorolac 30 mg | Drug: Ketorolac Injectable Solution<br>* ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes before induction of anesthesia then every 8 hours postoperatively<br>|
| Active Comparator: Ibuprofen group<br>ibuprofen 800 mg | Drug: Ibuprofen 800 mg<br>* ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes before induction of anesthesia then every 8 hours postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean dynamic VAS | average postoperative VAS | 24 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| static VAS | a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be') | 30 minutes, 2, 4, 6, 10, 18, 24 hours postoperatively | 
| dynamic VAS | a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be') | procedure (during knee flexion) | 
| time to first analgesia requirement | hours | period from extubation until first analgesic requirement during the first 24 hour postoperatively | 
| morphine consumption | mg | during the first 24 hour postoperatively | 
| time to independent movement | time from extubation to be able independently mobile e.g. using the bathroom | during the first 24 hour postoperatively | 
| patients satisfaction | on scale of 0 to 10 | at the end of 24 hour postoperative |