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Ibuprofen Versus Ketorolac For Postoperative Pain Relief After Cesarean Section

Primary Purpose

Pain, Postoperative

Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ibuprofen 800 mg
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring postoperative, pain relief, CESAREAN SECTION

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Parturients aged 20-30years. ASA physical satatus: II. Anticipated hospital stay for at least 24 hours. Refusal of spinal anaesthesia. Exclusion Criteria: Known allergy to the used drugs. Renal and hepatic impairement History of brochial asthma. Low platelets count (<70000). Bleeding diathesis and with history or risk of intracranial hemorrhage. Obese and morbidly obese parturients. GIT problems as gastritis or GI bleeding.

Sites / Locations

  • Ahmed S. Shehab

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Group (A):

Group (B):

Arm Description

30mg ketorolac in 200cc normal saline intravenously every 6hours for 24hours postoperatively.

800mg ibuprofen in 200cc normal saline intravenously every 6 hours for 24hours postoperatively.

Outcomes

Primary Outcome Measures

measurement of visual analogue score
measurement of visual analogue score during rest and movement . The Score range from 0- 10 . 0 means no pain and 10 indicates the worst pain ever

Secondary Outcome Measures

opioids requirements.
Total opioid cumulative requirement dose

Full Information

First Posted
April 18, 2023
Last Updated
October 1, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05907993
Brief Title
Ibuprofen Versus Ketorolac For Postoperative Pain Relief After Cesarean Section
Official Title
The Effectiveness Of Intravenous Ibuprofen Versus Intravenous Ketorolac For Postoperative Pain Relief After Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria 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 will be to evaluate the effectiveness of intravenous ibuprofen versus intravenous ketorolac for postoperative pain relief after caesarian section The Primary outcome is measurement of visual analogue score during rest and movement The Secondary outcome is measurement of 24 hours opioids requirements.
Detailed Description
METHODS 1. Preoperative assessment: All parturients included in the study will be assessed thoroughly by: Proper history taking Complete clinical examination. All needed laboratory investigations. 2. Patient preparation: On arrival to the operative theatre , an 18 G intravenous cannula will be inserted in a peripheral vein Steps of general anaesthesia will be explained to the parturients. Using a multichannel monitor (mindary) iMeC12 SHENZEN MINDRAY BIO-MEDICAL ELECTRONICS CO, LTD, CHINA, the parturients will be continuously monitored for: Non-invasive arterial blood pressure (NIBP) in (mmHg). Heart rate (beats/min). Oxygen saturation (percentage). End tidal carbon dioxide(mmhg). 3. Anaesthesia technique: Left uterine displacement will be maintained by a wedge under the right hip. Preoxygenation with 100% oxygen will be done for 3-5 minutes For both groups rapid sequence induction will be done with 2mg/kg propofol and 0.9 mg/kg rocuronium,50 microgram fentanyl followed by tracheal intubation and IPPV volume control. Anaesthesia will be maintained with 1.2% isoflurane in 100% Oxygen and 0.1 mg /kg roccuronium will be administrated if needed. After delivery oxytocin infusion 10 IU will be given After finishing operation , inhalational anaesthesia will be stopped and all parturients will receive 2mg/kg sugammadex when train of four is 75%. Then all parturients will be discharged to ward to be put under observation for 24 hours and they will receive NSAID immediately on arrival to the ward . Group A parturients will receive 30 mg ketorolac in 200 cc normal saline intravenously every 6 hours Group B parturients will receive 800 mg Ibuprofen in 200 cc normal saline intravenously every 6 hours All Parturients will receive 25 mg pethidine if visual analogue score (VAS) ≥4. MEASUREMENTS The following parameters will be measured for all parturients, in both groups: Demographic data: Age (years) Body Mass index ( kilogram/meters2) Weight (kilograms) Height (meters) Duration of surgery (minutes) Postoperative hemodynamics: Heart rate (beats/min) Blood pressure (mmHg) Baseline value immediately after extubation before giving any analgesia. Immediately and 2, 4, 6, 12, 24 hours after end of surgery. Visual analogue score: All parturients will be trained to use VAS. VAS at rest (VASR) and during movement (VASM) will be measured at 1,3,6,12,18,24 hours following surgery .The VAS score will be presented as 10 cm horizontal line anchored by the words "no pain"(corresponding to zero) and "worst pain possible"(corresponding to ten).The values will be scored as mild pain(from 1 to 3) ,moderate pain (from 4 to 6) and severe pain (from 7 to 10). If VAS is ≥4 parturients will receive 25mg pethidine iv. Opioid requirement During the first 24 hours after surgery(mg) The doses of pethidine required during the first 24 hours postoperatively will be calculated. Nocturnal awakening due to pain (percentage) The percentage of parturients who become awake at night due to pain Time to ambulate (minutes) The time the parturient takes to get out of bed and to do light activities such as sitting, standing or walking. Time to first analgesic dose (minutes) rescue analgesia The time when the patient require the first analgesic dose in the ward.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
postoperative, pain relief, CESAREAN SECTION

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (A):
Arm Type
No Intervention
Arm Description
30mg ketorolac in 200cc normal saline intravenously every 6hours for 24hours postoperatively.
Arm Title
Group (B):
Arm Type
Active Comparator
Arm Description
800mg ibuprofen in 200cc normal saline intravenously every 6 hours for 24hours postoperatively.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 800 mg
Intervention Description
Intravenous Ibuprofen versus intravenous Ketorolac for postoperative pain relief
Primary Outcome Measure Information:
Title
measurement of visual analogue score
Description
measurement of visual analogue score during rest and movement . The Score range from 0- 10 . 0 means no pain and 10 indicates the worst pain ever
Time Frame
after the surgery average 24 hours postoperative
Secondary Outcome Measure Information:
Title
opioids requirements.
Description
Total opioid cumulative requirement dose
Time Frame
after the surgery average 24 hours postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant Females
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parturients aged 20-30years. ASA physical satatus: II. Anticipated hospital stay for at least 24 hours. Refusal of spinal anaesthesia. Exclusion Criteria: Known allergy to the used drugs. Renal and hepatic impairement History of brochial asthma. Low platelets count (<70000). Bleeding diathesis and with history or risk of intracranial hemorrhage. Obese and morbidly obese parturients. GIT problems as gastritis or GI bleeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed S. Shehab, MD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed S. Shehab
City
Alexandria
ZIP/Postal Code
21431
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
17. there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers
IPD Sharing Time Frame
to the time when summary data are published
IPD Sharing Access Criteria
Accessible through the web site
Citations:
PubMed Identifier
31012040
Citation
Ekinci M, Ciftci B, Celik EC, Kose EA, Karakaya MA, Ozdenkaya Y. A Randomized, Placebo-Controlled, Double-Blind Study that Evaluates Efficacy of Intravenous Ibuprofen and Acetaminophen for Postoperative Pain Treatment Following Laparoscopic Cholecystectomy Surgery. J Gastrointest Surg. 2020 Apr;24(4):780-785. doi: 10.1007/s11605-019-04220-1. Epub 2019 Apr 22.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/31012040/
Description
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Ibuprofen Versus Ketorolac For Postoperative Pain Relief After Cesarean Section

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