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.: PACTR202509876934174 Date of Registration: 11/09/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of preemptive analgesia of intramuscular diclofenac versus pentazocine versus placebo on postoperative sequelae following mandibular third molar surgery.
Official scientific title Effects of preemptive analgesia of intramuscular diclofenac versus pentazocine on postoperative sequelae following mandibular third molar surgery: A randomized double-blind placebo-controlled study.
Brief summary describing the background and objectives of the trial Post-operative pain is the one of the most debilitating sequelae following third molar surgeries. The trial intends to elucidate the effects of preemptive analgesics ( Diclofenac & Pentazocine) on these aforementioned post-operative sequelae. A linear visual analog scale will be used to objectively measure pain perception in the study subjects.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 10/01/2024
Actual trial start date 10/01/2024
Anticipated date of last follow up 30/04/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Preemptive analgesic administration 75mg intramuscular diclofenac sodium Single dose Diclofenac will be administered 30 minutes before surgical extraction of the impacted mandibular molar. All participants will report their pain experiences using a visual analogue scale at specified intervals for a week following the extraction. There will be recall visits on post operative days 1, 3 and 7. At these visits mouth opening and facial swelling will be assessed. 30
Control Group Preemptive placebo administration 3ml normal saline intramuscularly Single dose Placebo will be administered 30 minutes before surgical extraction of the impacted mandibular molar. All participants will report their pain experiences using a visual analogue scale at specified intervals for a week following the extraction. There will be recall visits on post operative days 1, 3 and 7. At these visits mouth opening and facial swelling will be assessed. 30 Placebo
Experimental Group Preemptive analgesic adminstration 30mg intramuscular pentazocine Single dose Pentazocine will be administered 30 minutes before surgical extraction of the impacted mandibular molar. All participants will report their pain experiences using a visual analogue scale at specified intervals for a week following the extraction. There will be recall visits on post operative days 1, 3 and 7. At these visits mouth opening and facial swelling will be assessed. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients who were between 18 and 55 years of age that presented with an impacted mandibular third molar. • Patients who had signed the written informed consent form. • Patients who were literate and able to interpret their pain experience. • Impacted mandibular third molars with Pederson difficulty index less than or equal to a score 8 (moderate difficulty). • Patients with recurrent pericoronitis, unrestorable carious lesions, food packing, grossly fractured tooth, non-treatable pulpal pathology of an impacted mandibular third molar. • Patients classified as ASA I, using the American Society of Anaesthesiologists physical status classification (i.e. healthy individuals without systemic disease). • Patients who did not have active infection at the proposed surgical extraction site. • Patients with clinically documented allergies to the drugs to be used in the study. • Patients who had been taking opioid and non-opioid analgesics within 48 hours prior to their intended surgical extraction. • Patients with clinically documented immunocompromised diseases such as uncontrolled Diabetes mellitus, HIV/AIDS or bleeding disorders. • Pregnant and breastfeeding patients. • Patients with peptic ulcer disease. • Patients with endodontically or periodontally compromised ipsilateral second molar also requiring its extraction. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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 18/02/2025 Health Research Ethis Committee University of Benin Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
UBTH compound Uselu Road Ugbowo, Benin, Edo state Benin 300283 Nigeria
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 27/02/2025 Health research Ethics Committee Federal Medical Centre Asaba
Ethics Committee Address
Street address City Postal code Country
FMC compound Nnebisi road Asaba Asaba, Delta state 320104 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain experience Preoperatively, 30 minutes, 8 hours, day 1, day 2, day 3, day 4, day 5, day 6, day 7.
Secondary Outcome Mouth opening Preoperatively, day 1, day 3, day 7.
Secondary Outcome Facial swelling Preoperatively, day 1, day 3, day 7.
Secondary Outcome Rescue analgesic ingestion Postoperative day, day 1, day 2, day 3, day 4, day 5, day 6, day 7.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching Hospital UBTH compound Uselu road. Benin city Edo state Nigeria
Federal Medical Centre Asaba FMC compound Nnebisi road Asaba Delta state Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Babajide Onanuga UBTH compound Uselu road, Ugbowo Benin city Edo state 300283 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Babajide Onanuga UBTH compound Uselu road Ugbowo Benin city 300283 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Edetanlen Benlance Ekaniyere UBTH compound Uselu road, Ugbowo Benin city Edo state Nigeria
Prof. Obuekwe Ozomene Ndubuisi UBTH compound Uselu road, Ugbowo Benin City Edo state Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Babajide Onanuga jideonanuga1@gmail.com +2347037362110 UBTH compound Uselu road, Ugbowo
City Postal code Country Position/Affiliation
Benin city 300283 Nigeria Lead researcher
Role Name Email Phone Street address
Public Enquiries Babajide Onanuga jideonanuga1@gmail.com +2347037362110 UBTH compound Uselu road, Ugbowo
City Postal code Country Position/Affiliation
Benin city Edo state 300283 Nigeria Lead researcher
Role Name Email Phone Street address
Scientific Enquiries Babajide Onanuga jideonanuga1@gmail.com +2347037362110 UBTH compound Uselu road, Ugbowo
City Postal code Country Position/Affiliation
Benin city Edo state 300283 Nigeria Lead researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participant data and dictionaries will be available. Shared data will include all participants data collected after deidentification. Data will be available for any purpose. Informed Consent Form,Study Protocol Beginning 12 months and ending 36 months following article publication. Data access is controlled. Data analysis can be for any purpose. Data will be made available upon reasonable request. Proposals should be sent to the principal investigator (jideonanuga1@gmail.com)
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 07/09/2025 Entire public title was written using only upper case lettering. EFFECTS OF PREEMPTIVE ANALGESIA OF INTRAMUSCULAR DICLOFENAC VERSUS PENTAZOCINE VERSUS PLACEBO ON POSTOPERATIVE SEQUELAE FOLLOWING MANDIBULAR THIRD MOLAR SURGERY. Effects of preemptive analgesia of intramuscular diclofenac versus pentazocine versus placebo on postoperative sequelae following mandibular third molar surgery.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 07/09/2025 Entire scientific title was written using only upper case lettering. EFFECTS OF PREEMPTIVE ANALGESIA OF INTRAMUSCULAR DICLOFENAC VERSUS PENTAZOCINE ON POSTOPERATIVE SEQUELAE FOLLOWING MANDIBULAR THIRD MOLAR SURGERY: A RANDOMIZED DOUBLE BLIND PLACEBO-CONTROLLED STUDY. Effects of preemptive analgesia of intramuscular diclofenac versus pentazocine on postoperative sequelae following mandibular third molar surgery: A randomized double-blind placebo-controlled study.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 11/09/2025 PACTR Admin 10 Jan 2024
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 07/09/2025 18 year old participants are eligible. Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)