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Effect of Perioperative Single-Dose Oral Pregabalin and Intravenous Ibuprofen Combination Administration for Postoperative Pain After Third Molar Surgery

Comparisons the effects of preventive intravenous ibuprofen infusion and the combinations of intravenous ibuprofen infusion together with 2 different single oral dose of pregabalin on the postoperative pain after mandibular third molar extractions under local anesthesia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000969268
Enrollment
80
Registered
2018-06-08
Start date
2016-03-01
Completion date
2016-12-30
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We hypothesise that preoperative coadministration of ibuprofen and pregabalin combination is resulted better pain control than preoperative placebo or same dose of sole ibuprofen The objective of this study was to compare the efficacy of pregabalin and intravenous ibuprofen with regard to pain management and analgesic consumption after third molar surgery. Materials and methods: This was a prospective, randomized, controlled, double-blind study. Eighty patients who had planned for surgical extraction of impacted third molars were included in the study. The treatment groups included the following: (Group 1) premedicated with oral placebo and intravenous (IV) placebo, (Group 2) premedicated with oral placebo and 400 mg IV Ibuprofen, (Group 3) premedicated with 75 mg oral pregabalin and 400 mg IV ibuprofen, and (Group 4) premedicated with 150 mg oral pregabalin and 400 mg IV ibuprofen. The primary outcome measured was postoperative pain levels; secondary outcomes included the nonnarcotic analgesic requirement and the first rescue analgesic request time. The ratio of male/female participants, age, side effects, surgery difficulty, and duration of surgery were also evaluated.

Interventions

Single-Dose Oral Pregabalin and Intravenous Ibuprofen Combination Administration before oral surgery. The treatment groups included the following: (Group 1) premedicated with oral placebo and intravenous (IV) placebo, (Group 2) premedicated with oral placebo and 400 mg IV Ibuprofen, (Group 3) premedicated with 75 mg oral pregabalin and 400 mg IV ibuprofen, and (Group 4) premedicated with 150 mg oral pregabalin and 400 mg IV ibuprofen. Oral pregabalin (75 or 150 mg) (Lyrica; Pfizer, Inc., New Yor

Single-Dose Oral Pregabalin and Intravenous Ibuprofen Combination Administration before oral surgery. The treatment groups included the following: (Group 1) premedicated with oral placebo and intravenous (IV) placebo, (Group 2) premedicated with oral placebo and 400 mg IV Ibuprofen, (Group 3) premedicated with 75 mg oral pregabalin and 400 mg IV ibuprofen, and (Group 4) premedicated with 150 mg oral pregabalin and 400 mg IV ibuprofen. Oral pregabalin (75 or 150 mg) (Lyrica; Pfizer, Inc., New York, NY) and oral placebo (using similar looking cornstarch capsules) were administered to the corresponding treatment groups one hour before surgery. Intravenous ibuprofen (400 mg) (Intrafen; Gen Pharmaceuticals, Istanbul, Turkey) and intravenous placebo (sterile saline solution) were administered via intravenous infusion 30 minutes before surgery The medications were administered by a nurse who supervised by the director of the department, from the oral and maxillofacial surgery department.

Sponsors

Ataturk University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 24 Years
Healthy volunteers
No

Inclusion criteria

presence of soft tissue-impacted third molars, or partially or fully bony impacted mandibular third molars in a Pell-Gregory class II-B position that required surgical removal

Exclusion criteria

patient refusal, age outside of 18-24 years, ASA scores of III or IV, renal or hepatic failure, allergy to the study medication or related drugs, immune compromised status, psychological disorders, bleeding disorders, gastrointestinal system complaints, epilepsy or other neurological disorders, pregnancy or those breastfeeding, medication use less than 10 days before the surgery, preoperative inflammation, and lactose intolerance. Patients whose impacted teeth were exposed to the oral cavity before surgery and those, in which the duration of the surgical procedure exceeded 30 minutes, were also excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026