Cochrane · intervention · CD004624
Ibuprofen and/or paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth
Bailey, E, Worthington, HV, van Wijk, A, et al. · Cochrane Database of Systematic Reviews · 2013 · Cochrane Library
Oral HealthPain control and patient managementOral and maxillofacial surgery2 versionsAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
9
current version
GRADE rated
6
No studies
0
Included studies
7
as reported
No studies 0 · 0%Ungraded 3 · 33.3%Very low 0 · 0%Low 0 · 0%Moderate 2 · 22.2%High 4 · 44.4%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Patients of all health states without intolerances/allergies to the study drugs requiring surgical removal of a lower wisdom tooth or teeth requiring bone removal or with baseline moderate to severe pain; patients requiring removal of an additional tooth or teeth included; surgery under local anaesthesia, IV sedation or general anaesthesia; patients taking concurrent analgesia excluded | 2241 participants across 7 included trials; adults approximately 15 to 65 years, both sexes; all had surgery to remove a lower wisdom tooth or teeth requiring bone removal or causing moderate to severe pain (n=7) |
| Intervention | Ibuprofen, or the novel combination of paracetamol plus ibuprofen in a single tablet, given as a single postoperative oral dose in any dose and any formulation (immediate or slow release) | Ibuprofen 200 mg, 400 mg, 512 mg (n=7); novel combined paracetamol/ibuprofen tablet 250/100 mg, 500/200 mg, 1000/400 mg (n=2) |
| Comparison | Paracetamol (acetaminophen) given as a single postoperative oral dose in any dose and any formulation; the single constituent drugs (paracetamol or ibuprofen alone) serve as comparator for the combination | Paracetamol 500 mg, 600 mg, 1000 mg (n=7); single constituent drugs (paracetamol 1000 mg or ibuprofen 400 mg) as comparator for the combination (n=2) |
| Outcomes | Pain relief (VAS, categorical verbal rating, verbal numerical scale, global subjective efficacy ratings, other categorical scales) with derived TOTPAR and SPID over 2 to 6 hours (dichotomous: proportion with >=50% maximum pain relief); side effects (gastrointestinal, hepatic, renal) (binary); use of rescue medication within 6 to 8 hours | Proportion of patients with >50% maximum pain relief (TOTPAR) at 2 and 6 hours (n=6); use of rescue medication at 6 hours (n=5) and 8 hours (n=2); adverse events (n=7, narrative) |
| Study designs | All randomised controlled double-blinded clinical trials; cross-over studies included if wash-out at least 14 days; direct comparison of two or more trial drugs required; all used the third molar pain model | Randomised controlled double-blinded parallel-group trials (n=7) |
| Timing | Single postoperative dose; outcomes at 2 and 6 hours (rescue medication at 6 to 8 hours) | Single postoperative dose; TOTPAR at 2 and 6 hours; rescue medication at 6 hours (5 trials) or 8 hours (2 trials) |
Search date: 2013-05. Databases: Cochrane Oral Health Group's Trials Register (to 20 May 2013); Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 4); MEDLINE via OVID (1946 to 20 May 2013); EMBASE via OVID (1980 to 20 May 2013); meta Register of Controlled Trials (to 20 May 2013)
Questions and results
Current version onlyIbuprofen (single postoperative oral dose; 200 mg to 512 mg) vs Paracetamol (acetaminophen) (single postoperative oral dose; 600 mg to 1000 mg)
Population: Patients with pain after surgical removal of lower wisdom teeth (third molars) requiring bone removal or with baseline moderate to severe pain; adults approximately 15 to 65 years, both sexes
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Proportion of patients with >50% maximum pain relief (TOTPAR) over 6 hours 6 hours postdosing · Ibuprofen 400 mg vs paracetamol 1000 mg | RR 1.47 [1.28, 1.69] 56 per 100 vs 83 per 100 | 5 studies · 646 participants | High |
Proportion of patients with >50% maximum pain relief (TOTPAR) over 2 hours 2 hours postdosing · Ibuprofen 400 mg vs paracetamol 1000 mg | RR 1.30 [1.09, 1.55] 62 per 100 vs 81 per 100 | 5 studies · 645 participants | High |
Patients not using rescue medication at 6 hours 6 hours postdosing · Ibuprofen 400 mg vs paracetamol 1000 mg | RR 1.50 [1.25, 1.79] 50 per 100 vs 75 per 100 | 4 studies · 542 participants | High |
Patients using rescue medication at 8 hours 8 hours postdosing | RR 2.02 [1.57, 2.60] | 2 studies | Ungraded |
Adverse events Study period (immediate postoperative) | The majority of adverse events were minor in nature and usually included nausea, vomiting, headaches and dizziness. Side effect profiles have not been included in a meta-analysis as multiple adverse events were… | 7 studies | Ungraded |
Combined paracetamol plus ibuprofen in a single tablet (e.g. paracetamol 1000 mg/ibuprofen 400 mg or 500/200 mg) vs Single drugs given separately (paracetamol 1000 mg or ibuprofen 400 mg)
Population: Patients with pain after surgical removal of lower wisdom teeth (third molars) requiring bone removal or with baseline moderate to severe pain; adults approximately 15 to 65 years, both sexes
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Adverse events Study period (immediate postoperative) | The majority of adverse events were minor in nature and usually included nausea, vomiting, headaches and dizziness. Side effect profiles have not been included in a meta-analysis as multiple adverse events were… | 2 studies | Ungraded |
Proportion of patients with >50% maximum pain relief (TOTPAR) over 6 hours 6 hours postdosing · Paracetamol 1000 mg/ibuprofen 400 mg vs paracetamol 1000 mg or ibuprofen 400 mg | RR 1.77 [1.32, 2.39] 38 per 100 vs 67 per 100 | 1 study · 170 participants | Moderate Downgraded: imprecision |
Proportion of patients with >50% maximum pain relief (TOTPAR) over 2 hours 2 hours postdosing · Paracetamol 1000 mg/ibuprofen 400 mg vs paracetamol 1000 mg or ibuprofen 400 mg | RR 1.29 [0.91, 1.85] 37 per 100 vs 48 per 100 | 1 study · 170 participants | Moderate Downgraded: imprecision |
Patients not using rescue medication at 8 hours 8 hours postdosing · Paracetamol 1000/500 mg/ibuprofen 400/200 mg vs single constituent drugs | RR 1.60 [1.36, 1.88] 50 per 100 vs 80 per 100 | 2 studies · 467 participants | High |
Ibuprofen (single dose, oral, any dose/formulation) vs Paracetamol (acetaminophen) (single dose, oral, any dose/formulation)
Population: Patients of all health states requiring surgical removal of a lower wisdom tooth or teeth requiring bone removal or with baseline moderate to severe pain
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR Single dose; pain relief over 4 to 6 hours (planned) | no estimate extracted | 0 studies | No studies |