Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202302774048699 Date of Approval: 08/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title COMPARISON OF PRE-EMPTIVE ANALGESICS IN POST-OPERATIVE PAIN CONTROL
Official scientific title COMPARISON OF PRE-EMPTIVE PARACETAMOL, IBUPROFEN, AND PLACEBO ADMINISTRATION IN REDUCING POST-OPERATIVE PAIN IN DENTOALVEOLAR EXTRACTION AT THE UNIVERSITY OF BENIN TEACHING HOSPITAL, BENIN CITY.
Brief summary describing the background and objectives of the trial It was well documented that the postoperative pain associated with surgical tooth extractions can range in intensity from moderate to severe during the first 24 hours. Pain intensity reaches its maximum peak between 6 and 8 hours when a conventional local anesthetic is used. In particular, postoperative pain increases the patient's suffering and anxiety, and can disrupt the homeostasis of the circulatory and endocrine systems. Since it is also reported that postoperative pain can have a negative influence on wound healing, reliable and fast-onset analgesia is needed. Nonsteroidal anti-inflammatory drugs are one of the treatment options to be used as pain relief for surgical teeth extraction by administering pre-operative analgesics, the postoperative pain intensity can be subsided and delayed as a result of the reduction in the amount of pain triggers (prostaglandins) discharged into the site of the injuries. This study is designed to scientifically determine the pre-emptive effectiveness of paracetamol and ibuprofen which are common analgesics occasionally used by dentist in the management of post extraction pain in the study location. The study is also intended to be used to establish a protocol for the use of these drugs in a bid to appropriately manage post-extraction pain in order to give the patient the best and least painful care possible. 1. To determine the effectiveness of paracetamol in the management of post extraction pain using the visual analogue scale. 2. To determine the effectiveness of Ibuprofen in the management of post extraction pain using the visual analogue scale 3. To determine the difference (if any) in the effectiveness of paracetamol and ibuprofen in the management of post-extraction pain using the visual analogue scale. 4. The maximum time taken for pain perception for paracetamol and ibuprofen groups-that is time from the end of the surgery to the time at which rescue medication ibuprofen 400mg was necessary for
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2021
Actual trial start date 22/02/2021
Anticipated date of last follow up 31/01/2022
Actual Last follow-up date 21/02/2022
Anticipated target sample size (number of participants) 69
Actual target sample size (number of participants) 69
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group GROUP C Calcium lactate 300mg stat once tabs calcium lactate 300mg is given 30 minutes before the commencement of the extraction 23 Placebo
Experimental Group Group A Tabs Paracetamol 1000mg once Tabs Paracetamol 1000mg stat is given 30 minutes before the commencement of the extraction 23
Experimental Group Group B Tabs Ibuprofen 400mg stat once Tabs Ibuprofen 400mg stat was given 30 minutes before commencement of extraction 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. Minimum age of 18 years. b. Patient who consent to the study c. Patients who have indications for tooth extraction d. Patients who can read and understand the pain score sheet. a. Patients younger than 18 years. b. Patients who may have taken analgesics within the past 4 hours. c. Patients who are allergic to NSAIDs, paracetamol, or local anaesthetic agents. d. History of gastrointestinal disorders, oesophageal reflux, active asthma, decreased hepatic function, hemorrhagic disorder. e. Pregnant or nursing mothers. f. Patients who object to participating in the study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/02/2021 Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ugbowo Benin 1111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Level of post-operative pain immediate post-extraction, 1hour, 2hours, 6hours post-extraction
Secondary Outcome side effects of medication immediate post extraction, 1hour, 2hours, 6hours post extraction
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Universtity of Benin Teaching Hospital Ugbowo Benin Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Mercy Okoh Department of Oral Medicine and Oral Pathology, University of Benin Teaching Hopsital Benin Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Mercy Okoh Department of Oral Medicine and Pathology, University of Benin Teaching Hospital Benin Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mercy Okoh mercy.okoh@uniben.edu +2348077082732 Department of Oral Medicine and Pathology, University of Benin Teaching Hospital
City Postal code Country Position/Affiliation
Benin Nigeria Associate Professor
Role Name Email Phone Street address
Public Enquiries Mercy Okoh mercy.okoh@uniben.edu +2348077082732 Department of Oral Medicine and Pathology, University of Benin Teaching Hospital
City Postal code Country Position/Affiliation
Benin Nigeria Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Mercy Okoh mercy.okoh@uniben.edu +2348077082732 Department of Oral Medicine and Pathology, University of Benin Teaching Hospital
City Postal code Country Position/Affiliation
Benin Nigeria Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual Participant data excluding personal identification information will be shared Clinical Study Report,Statistical Analysis Plan,Study Protocol within 2 years of study completion Controlled access, all data analysis, access to study results will be granted on requests to researchers in relevant fields of study.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information