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Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy

Primary Purpose

Postoperative Pain, Hysterectomy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ketorolac Injectable Solution
Ibuprofen 800 mg
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Ahmed Mohamed Hasanin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ketorolac group

Ibuprofen group

Arm Description

ketorolac 30 mg

ibuprofen 800 mg

Outcomes

Primary Outcome Measures

mean dynamic VAS
average postoperative VAS

Secondary Outcome Measures

static VAS
a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
dynamic VAS
a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
time to first analgesia requirement
hours
morphine consumption
mg
time to independent movement
time from extubation to be able independently mobile e.g. using the bathroom
patients satisfaction
on scale of 0 to 10

Full Information

First Posted
November 3, 2022
Last Updated
July 26, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05610384
Brief Title
Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy
Official Title
Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Hysterectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac group
Arm Type
Active Comparator
Arm Description
ketorolac 30 mg
Arm Title
Ibuprofen group
Arm Type
Active Comparator
Arm Description
ibuprofen 800 mg
Intervention Type
Drug
Intervention Name(s)
Ketorolac Injectable Solution
Intervention Description
ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes before induction of anesthesia then every 8 hours postoperatively
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 800 mg
Intervention Description
ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes before induction of anesthesia then every 8 hours postoperatively.
Primary Outcome Measure Information:
Title
mean dynamic VAS
Description
average postoperative VAS
Time Frame
24 hour after surgery
Secondary Outcome Measure Information:
Title
static VAS
Description
a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Time Frame
30 minutes, 2, 4, 6, 10, 18, 24 hours postoperatively
Title
dynamic VAS
Description
a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Time Frame
procedure (during knee flexion)
Title
time to first analgesia requirement
Description
hours
Time Frame
period from extubation until first analgesic requirement during the first 24 hour postoperatively
Title
morphine consumption
Description
mg
Time Frame
during the first 24 hour postoperatively
Title
time to independent movement
Description
time from extubation to be able independently mobile e.g. using the bathroom
Time Frame
during the first 24 hour postoperatively
Title
patients satisfaction
Description
on scale of 0 to 10
Time Frame
at the end of 24 hour postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ahmed Mohamed Hasanin
City
Cairo
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data will be share upon reasonable request from the PI

Learn more about this trial

Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy

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