Postoperative Pain, Wisdom Tooth
Conditions
Keywords
Third molar
Brief summary
The purpose of this study is to investigate whether robust analgesic regime (protective analgesia) can improve postoperative pain experience for patients undergoing lower wisdom teeth extraction under day case general anaesthetic.
Detailed description
The aim of the study was to demonstrate and improve postoperative pain experience using protective analgesia for patients undergoing oral surgery under day case general anaesthesia. The primary objective was to investigate the efficiency of protective analgesia using combined effects of sustained release ibuprofen and bupivacaine nerve block in attenuation of postoperative pain following impacted third molar surgery under day case general anaesthesia. The secondary objective was to document the safety and tolerability profile of conventional release versus sustained released ibuprofen with bupivacaine block in subjects undergoing impacted third molar surgery under day case general anaesthesia.
Interventions
DRUGBrufen retard
Single dose 2 x 800mg tablets 2 hours prior to surgery
DRUGibuprofen
Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery
DRUGBupivacaine
Up to 10ml of Bupivacaine 0.5% with 1:200,000 Adrenaline given prior to surgical incision as inferior alveolar nerve block and long buccal nerve infiltration.
Sponsors
Manchester University NHS Foundation Trust
University of Manchester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy male and female patients aged 18 years and over * patients requiring removal of one or more third molars, with at lease one completely or partially impacted in the mandible needing bone removal
Exclusion criteria
* history of allergy to NSAIDs * pregnant * history of GI disease * history of bleeding disorders * alcohol dependancy * drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Needing Rescue Medication | At 6 hours | Number of patients who required rescue medication within 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Intensity | 30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery | Mean VAS scores of pain intensity for each time points |
| Time to Rescue | Between 30mins and 48 hours | Time taken for rescue medication requirement |
| Pain Control/Relief | 48 hours after surgery (end of study) | Patient satisfaction scores |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Ibuprofen | 60 |
| Brufen Retard | 62 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 12 | 12 |
Baseline characteristics
| Characteristic | Brufen Retard | Conventional Ibuprofen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 60 Participants | 122.0 Participants |
| Age Continuous | 28.82 years STANDARD_DEVIATION 6.262 | 28.71 years STANDARD_DEVIATION 5.809 | 28.77 years STANDARD_DEVIATION 6.013 |
| Region of Enrollment United Kingdom | 62 participants | 60 participants | 122.0 participants |
| Sex: Female, Male Female | 16 Participants | 40 Participants | 56.0 Participants |
| Sex: Female, Male Male | 46 Participants | 20 Participants | 66.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | — / — | — / — |
| serious Total, serious adverse events | — / — | — / — |
Outcome results
Primary
Number of Patients Needing Rescue Medication
Number of patients who required rescue medication within 6 hours
Time frame: At 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Ibuprofen | Number of Patients Needing Rescue Medication | 32 Participants |
| Brufen Retard | Number of Patients Needing Rescue Medication | 29 Participants |
Secondary
Mean Pain Intensity
Mean VAS scores of pain intensity for each time points
Time frame: 30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery
Secondary
Pain Control/Relief
Patient satisfaction scores
Time frame: 48 hours after surgery (end of study)
Secondary
Time to Rescue
Time taken for rescue medication requirement
Time frame: Between 30mins and 48 hours