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| Name | Class |
|---|---|
| Manchester University NHS Foundation Trust | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional ibuprofen | Active Comparator |
| |
| Brufen retard | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brufen retard | Drug | Single dose 2 x 800mg tablets 2 hours prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Needing Rescue Medication | Number of patients who required rescue medication within 6 hours | At 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Intensity | Mean VAS scores of pain intensity for each time points | 30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery |
| Time to Rescue | Time taken for rescue medication requirement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Coulthard, BDS FDS PhD | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Manchester and Manchester Children's NHS University Hospitals | Manchester | Lancashire | M13 9PL | United Kingdom | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Ibuprofen | |
| FG001 | Brufen Retard |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Ibuprofen | |
| BG001 | Brufen Retard | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Needing Rescue Medication | Number of patients who required rescue medication within 6 hours | Posted | Number | Participants | At 6 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Ibuprofen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Sin L Yong | University of Manchester | 01612756806 | sin.l.yong@manchester.ac.uk |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| ibuprofen | Drug | Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery |
|
|
| Bupivacaine | Drug | 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. |
|
|
| Between 30mins and 48 hours |
| Pain Control/Relief | Patient satisfaction scores | 48 hours after surgery (end of study) |
| Central Manchester NHS Foundation Trust |
| Manchester |
| Lancashire |
| M13 9PL |
| United Kingdom |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Mean Pain Intensity | Mean VAS scores of pain intensity for each time points | Not Posted | Mean | Full Range | VAS pain score 0 to 100 | 30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery |
| Secondary | Time to Rescue | Time taken for rescue medication requirement | Not Posted | Median | 95% Confidence Interval | Minutes | Between 30mins and 48 hours |
| Secondary | Pain Control/Relief | Patient satisfaction scores | Not Posted | Mean | Full Range | Numerical satisfaction score 0 to 10 | 48 hours after surgery (end of study) |
| EG001 | Brufen Retard |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000813 |
| Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |