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.: PACTR202311897703701 Date of Approval: 16/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Postoperative pain control and quality of life following the use of preemptive celecoxib in mandibular third molar surgery
Official scientific title Postoperative pain control and quality of life following the use of preemptive celecoxib in mandibular third molar surgery
Brief summary describing the background and objectives of the trial BACKGROUND: Mandibular third molar surgery is an invasive oral surgical procedure that is often associated with pain. The pain following the surgery can be frustrating to both patients and surgeons and could impact negatively on the patient's health-related quality of life. Preemptive analgesia for the control of postoperative pain is targeted at preventing central sensitization before the commencement of the surgical procedure. Some studies revealed promising outcomes with this method while others have different views on its benefit and has led to controversy among researchers on the subject. The aim of this research is to study postoperative pain control and quality of life following the use of preemptive celecoxib in mandibular third molar surgery. OBJECTIVES: The objective of this study is to assess the benefit of preemptive analgesia on postoperative pain control and the impact on the health-related quality of life of patients following mandibular third molar surgery.
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 26/09/2023
Actual trial start date 26/09/2023
Anticipated date of last follow up 12/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NHREC2801AKTHEC3488 National Health Research Ethics Committee, Nigeria
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Preemptive analgesia Single dose of capsule Celecoxib 200mg given 1 hour before procedure Once (one hour before procedure) Double blind, Randomized control study The study group (experimental group) shall receive Celebrex capsule containing 200mg one hour before surgical extraction of impacted mandibular third molar. 31
Control Group Placebo Control group Single Capsule containing placebo (edible starch) given an hour before the procedure one hour before the procedure (single dose given preemptively) Double blind, Randomized control study Preemptive placebo 31 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients within the age ranges of 18 to 50 years. 2. Patients who shall be willing to keep instructions and follow-up appointments. 3. Patients with mandibular third molar impaction requiring surgical extraction 4. Patients who give their consent to be part of the study 5. American Society of Anaesthesiologist physical status classification I (ASA I) patients 1. Patients with a history of allergy to celecoxib. 2. Patients who are allergic to penicillins and metronidazole 3. Patients who used NSAIDs or any other analgesic within 24 hours before the procedure 4. Patients with a bleeding disorder or on anticoagulant 5. Patients with peptic ulcer disease, kidney disease, asthma or any medical condition that contradict the use of NSAIDs. 6. Pregnant women 7. Patients with periapical cysts or tumours related to the impacted third molar 8. Patients that could not be able to rate their pain intensity on the VAS due to medical conditions such as problems with vision, mental retardation, cognitive disorder, or any other reason. 9. Patients who smoke, take alcohol or abuse drugs (illicit drugs) Adult: 19 Year-44 Year 18 Year(s) 50 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 04/08/2023 National Health Research Ethics Committee Aminu Kano Teaching Hospital Kano Nigeria
Ethics Committee Address
Street address City Postal code Country
Zaria road, P.M.B 3452, Kano Kano PMB 3452 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity to measured by the participants following the procedure using the Visual Analogue Scale VAS 4-hour, 8-hour, 16-hour and 24-hour postoperatively
Primary Outcome Health related quality of life 7th postoperative day
Secondary Outcome Rescue analgesic demand recorded by the number of times the rescue analgesia was required/taken by the participants within the first 24 hours within 24-hour postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Oral and Maxillofacial Surgery Aminu Kano Teaching Hospital Kano Along Zaria Road, P.M.B. 3452, Kano Kano PMB 3452 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Stephen Solomon Darmanawa tudun fulani, behind MDR filling Station, Kano Kano PMB 3452 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stephen Solomon Darmanawa tudun Fulani, behind MDR filling Station, Kano Kano PMB 3452 Nigeria self sponsored
COLLABORATORS
Name Street address City Postal code Country
Professor Akinwale Efunkoya Aminu Kano Teaching Hospital, Zaria road Kano KAno PMB 3452 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stephen Solomon marshallsteve828@yahoo.com +2348036800828 Darmanawa tudun Fulani, behind MDR fillng station, kano
City Postal code Country Position/Affiliation
Kano Nigeria Senior Registrar Oral and Maxillofacial surgery Aminu kano Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Stephen Solomon marshallsteve828@yahoo.com +2348036800828 Darmanawa-Tudun Fulani, Behind MDR filling Station, Kano
City Postal code Country Position/Affiliation
Kano Nigeria Senior registrar department of oral and maxillofacial surgery Aminu kano teaching hospital
Role Name Email Phone Street address
Public Enquiries Akinwale Efunkoya akinefunks12@gmail.com +2348065454401 Aminu kano teaching hospital, zaria road
City Postal code Country Position/Affiliation
Kano Nigeria Professor Oral and Maxillofacial surgeon Aminu Kano Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IPD will be shared as a summary result within the trial registration record. Statistical Analysis Plan 12 months Open access.
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