Ibuprofen and/or paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth

Edmund Bailey; Helen V Worthington; Arjen van Wijk; Julian M Yates; Paul Coulthard; Zahid Afzal

doi:10.1002/14651858.CD004624.pub2

Cochrane Database of Systematic Reviews

Ibuprofeno y paracetamol (acetaminofeno) para el alivio del dolor posterior a la extracción quirúrgica de la muela de juicio inferior

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DOI:

https://doi.org/10.1002/14651858.CD004624.pub2 Copiar DOI

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Cochrane Database of Systematic Reviews

Versión publicada:

12 diciembre 2013see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Salud oral

Copyright:

Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Edmund Bailey

Correspondencia a: Department of Oral and Maxillofacial Surgery, School of Dentistry, The University of Manchester, Manchester, UK

[email protected]
Helen V Worthington

Cochrane Oral Health Group, School of Dentistry, The University of Manchester, Manchester, UK
Arjen van Wijk

Social Dentistry and Behavioural Sciences, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, Netherlands
Julian M Yates

Department of Oral and Maxillofacial Surgery, School of Dentistry, The University of Manchester, Manchester, UK
Paul Coulthard

Department of Oral and Maxillofacial Surgery, School of Dentistry, The University of Manchester, Manchester, UK
Zahid Afzal

Oral and Maxillofacial Surgery, City Hospital, Birmingham, UK

Contributions of authors

Background and original concept: Paul Coulthard (PC), Zahid Afzal (ZA), Edmund Bailey (EB).
Identification of included studies: EB, PC, Helen Worthington (HW).
Risk of bias: EB, Julian M Yates (JMY).
Data analysis: EB, HW, Arjen van Wijk (AvW).
Results and conclusions: EB, PC, HW.

Sources of support

Internal sources

The University of Manchester, UK.
The Sahlgrenska Academy at Goteborg University, Sweden.
The University of Amsterdam, Netherlands.
MAHSC, UK.

The Cochrane Oral Health Group is supported by the Manchester Academic Health Sciences Centre (MAHSC) and the NIHR Manchester Biomedical Research Centre.

External sources

Swedish Medical Research Council (9495), Sweden.
Hjalmar Svensson Research Fund, Sweden.
National Institute for Health Research (NIHR), UK.

CRG funding acknowledgement:
The NIHR is the largest single funder of the Cochrane Oral Health Group.

Disclaimer:
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health.
Cochrane Oral Health Group Global Alliance, UK.

All reviews in the Cochrane Oral Health Group are supported by Global Alliance member organisations (British Association of Oral Surgeons, UK; British Orthodontic Society, UK; British Society of Paediatric Dentistry, UK; British Society of Periodontology, UK; Canadian Dental Hygienists Association, Canada; National Center for Dental Hygiene Research & Practice, USA; Mayo Clinic, USA; New York University College of Dentistry, USA; and Royal College of Surgeons of Edinburgh, UK) providing funding for the editorial process (http://ohg.cochrane.org/).

Declarations of interest

Review authors have no interests to declare.

Acknowledgements

We wish to thank Anne Littlewood (Cochrane Oral Health Group) for her assistance with literature searching and Luisa Fernandez Mauleffinch (Cochrane Oral Health Group) for her help with the preparation of this review.

Version history

Published

Title

Stage

Authors

Version

2013 Dec 12

Ibuprofen and/or paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth

Review

Edmund Bailey, Helen V Worthington, Arjen van Wijk, Julian M Yates, Paul Coulthard, Zahid Afzal

https://doi.org/10.1002/14651858.CD004624.pub2

2003 Oct 20

Ibuprofen versus paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth

Protocol

Zahid Afzal, Paul Coulthard, Marco Esposito, Lee Hooper, Kiaran Weil, Helen V Worthington, Arjen van Wijk

https://doi.org/10.1002/14651858.CD004624

Differences between protocol and review

The original protocol was written focusing purely on the individual administration of ibuprofen versus paracetamol. Since publication of the protocol a new combination drug (marketed as Nuromol), containing both paracetamol and ibuprofen in the same tablet, was launched in the United Kingdom. This drug has shown promising results to date and we have chosen to also compare the combined drug with the single drugs using this model.

Quality assessment has been updated to reflect the change to risk of bias assessment.

The following subgroup analysis was removed as the review only focuses on postoperative pain relief: the time of administration of ibuprofen or paracetamol differs: preoperative versus postoperative.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Ibuprofen versus paracetamol, Outcome 1 Proportion of patients with > 50% max pain relief (TOTPAR) over 6 hours.

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Analysis 1.2

Comparison 1 Ibuprofen versus paracetamol, Outcome 2 Proportion of patients with > 50% max pain relief (TOTPAR) over 2 hours.

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Analysis 1.3

Comparison 1 Ibuprofen versus paracetamol, Outcome 3 Number of patients using rescue medication at 6 hours.

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Analysis 1.4

Comparison 1 Ibuprofen versus paracetamol, Outcome 4 Number of patients using rescue medication at 8 hours.

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Analysis 2.1

Comparison 2 Combined (ibuprofen and paracetamol) versus single drugs, Outcome 1 Proportion of patients with > 50% max pain relief (TOTPAR) over 6 hours.

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Analysis 2.2

Comparison 2 Combined (ibuprofen and paracetamol) versus single drugs, Outcome 2 Proportion of patients with > 50% max pain relief (TOTPAR) over 2 hours.

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Analysis 2.3

Comparison 2 Combined (ibuprofen and paracetamol) versus single drugs, Outcome 3 Number of patients using rescue medication at 8 hours.

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Summary of findings for the main comparison. Ibuprofen versus paracetamol for pain relief following the surgical removal of lower wisdom teeth

Ibuprofen versus paracetamol for pain relief following the surgical removal of lower wisdom teeth
Patient or population: Patients with pain after surgical removal of lower wisdom teeth Intervention: Ibuprofen Control: Paracetamol
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed¹ risk	Corresponding risk
	Control	Ibuprofen
Proportion of patients with > 50% maximum pain relief (TOTPAR) over 6 hours ‐ Ibuprofen 400 mg versus paracetamol 1000 mg Categorical scale Follow‐up: 6 hours	Study population		RR 1.47 (1.28 to 1.69)	646 (5 studies)	⊕⊕⊕⊕ high	When all doses considered RR = 1.45 (95% CI 1.31 to 1.61) (6 studies, 926 participants; high quality evidence)
	56 per 100	83 per 100 (72 to 95)
Proportion of patients with > 50% maximum pain relief (TOTPAR) over 2 hours ‐ Ibuprofen 400 mg versus paracetamol 1000 mg Categorical scale Follow‐up: 2 hours	Study population		RR 1.30 (1.09 to 1.55)	645 (5 studies)	⊕⊕⊕⊕ high	When all doses considered RR = 1.29 (95% CI 1.13 to 1.46) (6 studies, 926 participants; high quality evidence)
	62 per 100	81 per 100 (68 to 97)
*Number of patients not using rescue medication at 6 hours (non‐event)* ‐ Ibuprofen 400 mg versus paracetamol 1000 mg Follow‐up: 6 hours	Study population		RR 1.50 (1.25 to 1.79)	542 (4 studies)	⊕⊕⊕⊕ high	When all doses considered RR = 1.44 (95% CI 1.13 to 1.64) (5 studies, 823 participants; high quality evidence)
	50 per 100	75 per 100 (63 to 90)
Adverse events	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 recorded in single patients. However, the differences in the observed adverse events for ibuprofen and paracetamol were small
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ This is the median control group risk based on paracetamol being the control group.

Summary of findings for the main comparison. Ibuprofen versus paracetamol for pain relief following the surgical removal of lower wisdom teeth

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Summary of findings 2. Combined (ibuprofen and paracetamol) versus single drugs for pain relief after surgical removal of lower wisdom teeth

Combined (ibuprofen and paracetamol) versus single drugs for pain relief after surgical removal of lower wisdom teeth
Patient or population: Patients with pain after surgical removal of lower wisdom teeth Intervention: Combined (ibuprofen and paracetamol) versus single drugs Control: Single drugs
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed¹ risk	Corresponding risk
	Control	Combined (ibuprofen and paracetamol)
Proportion of patients with > 50% maximum pain relief (TOTPAR) over 6 hours ‐ Paracetamol 1000 mg/ibuprofen 400 mg versus paracetamol 1000 mg or ibuprofen 400 mg Categorical scale Follow‐up: 6 hours	Study population		RR 1.77 (1.32 to 2.39)	170 (1 study)	⊕⊕⊕⊝ moderate²
	38 per 100	67 per 100 (50 to 91)
Proportion of patients with > 50% maximum pain relief (TOTPAR) over 2 hours ‐ Paracetamol 1000 mg/ibuprofen 400 mg versus paracetamol 1000 mg or ibuprofen 400 mg Categorical scale Follow‐up: 2 hours	Study population		RR 1.29 (0.91 to 1.85)	170 (1 study)	⊕⊕⊕⊝ moderate²
	37 per 100	48 per 100 (34 to 68)
Number of patients not using rescue medication at 8 hours ‐ Paracetamol 1000 mg/ibuprofen 400 mg versus paracetamol 1000 mg or ibuprofen 400 mg Follow‐up: 8 hours	Study population		RR 1.60 (1.36 to 1.88)	467 (2 studies)	⊕⊕⊕⊕ high
	50 per 100	80 per 100 (68 to 94)
Adverse events	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 recorded in single patients. However, the differences in the observed adverse events for ibuprofen and paracetamol were small
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ This is the median control group risk based on paracetamol/ibuprofen as single drugs being the control group. ² Quality of evidence downgraded due to single study and serious imprecision.

Summary of findings 2. Combined (ibuprofen and paracetamol) versus single drugs for pain relief after surgical removal of lower wisdom teeth

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Table 1. Doses used in included studies

	Daniels 2009	Forbes 1990	Hersch 2000*	Mehlisch 1995	Mehlisch 2010	Mehlisch 2010a	Olson 2001*
Paracetamol 500 mg						√
Paracetamol 600 mg		√
Paracetamol 1000 mg	√		√	√	√	√	√
Ibuprofen 200 mg			√			√
Ibuprofen 400 mg	√	√	√	√	√	√	√
Ibuprofen 512 mg	√
Paracetamol 250 mg/ibuprofen 100 mg						√
Paracetamol 500 mg/ibuprofen 200 mg					√	√
Paracetamol 1000 mg/ibuprofen 400 mg					√	√
*Liquigel formula.

Table 1. Doses used in included studies

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Table 2. Use of rescue medication

Study	Use of rescue medication (RM)
	Mean time to RM	Use of RM (%)	Use of RM (n)	Total	Observation period
Daniels 2009					6 hours
Paracetamol 1000		44	35	80
Ibuprofen 400		23	18	80
Ibuprofen 512		33	26	80
Forbes 1990					6 hours
Paracetamol 600	3.89 hours	81	29	36
Ibuprofen 400	4.63 hours	63	20	32
Hersch 2000					6 hours
Paracetamol 1000		51	32	63
Ibuprofen 200		31	19	61
Ibuprofen 400		22	13	59
Mehlisch 1995					6 hours
Paracetamol 1000		60	60	101
Ibuprofen 400		26	25	98
Mehlisch 2010					8 hours
Paracetamol 1000	261 minutes	71	24	34
Ibuprofen 400	296 minutes	68	47	69
Paracetamol 1000/ibuprofen 400	376 minutes	31	21	67
Paracetamol 500/ibuprofen 200	329 minutes	61	20	33
Mehlisch 2010a					8 hours in phase 1
Paracetamol 500		74	56	76
Paracetamol 1000		69	51	74
Ibuprofen 200		39	29	75
Ibuprofen 400		28	21	74
Paracetamol 250/ibuprofen 100		38	27	71
Paracetamol 1000/ibuprofen 400		28	42	149
Paracetamol 500/ibuprofen 200		22	31	143
Olson 2001					6 hours
Paracetamol 1000		38	25	66
Ibuprofen 400		21	14	67

Table 2. Use of rescue medication

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Table 3. Adverse events

Study	Adverse events (AE)
	Total AE (n)	Total AE %	Serious/Severe AE	Serious/Severe AE %
Daniels 2009
Paracetamol 1000	25 (81)	31	3	12
Ibuprofen 400	19 (80)	24	1	3
Ibuprofen 512	24 (80)	30	2	6
Forbes 1990
Paracetamol 600	5 (41)	12	Not specified	Not specified
Ibuprofen 400	8 (43)	19	Not specified	Not specified
Hersch 2000
Paracetamol 1000	12 (63)	19	0	0
Ibuprofen 200	7 (61)	11	0	0
Ibuprofen 400	4 (59)	7	0	0
Mehlisch 1995
Paracetamol 1000	17 (101)	17	0	0
Ibuprofen 400	12 (98)	12	0	0
Mehlisch 2010
Paracetamol 1000	24 (34)	71	11	46
Ibuprofen 400	39 (69)	57	14	36
Paracetamol 1000/ibuprofen 400	38 (67)	57	11	29
Paracetamol 500/ibuprofen 200	14 (33)	42	6	43
Mehlisch 2010a
Paracetamol 500	38 (76)	50	7	18
Paracetamol 1000	30 (74)	40	5	17
Ibuprofen 200	31 (75)	41	7	23
Ibuprofen 400	33 (74)	45	5	15
Paracetamol 250/ibuprofen 100	22 (71)	31	8	36
Paracetamol 1000/ibuprofen 400	44 (149)	30	15	34
Paracetamol 500/ibuprofen 200	51 (143)	36	7	14
Olson 2001
Paracetamol 1000	10 (66)	15	1	10
Ibuprofen 400	7 (67)	11	2	29

Table 3. Adverse events

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Comparison 1. Ibuprofen versus paracetamol

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Proportion of patients with > 50% max pain relief (TOTPAR) over 6 hours Show forest plot	6	926	Risk Ratio (M‐H, Random, 95% CI)	1.45 [1.31, 1.61]

1.1 Ibuprofen 200 mg versus paracetamol 1000 mg	1	92	Risk Ratio (M‐H, Random, 95% CI)	1.29 [0.90, 1.84]
1.2 Ibuprofen 400 mg versus paracetamol 1000 mg	5	646	Risk Ratio (M‐H, Random, 95% CI)	1.47 [1.28, 1.69]
1.3 Ibuprofen 400 mg versus paracetamol 600 mg	1	68	Risk Ratio (M‐H, Random, 95% CI)	2.41 [1.13, 5.16]
1.4 Ibuprofen 512 mg versus paracetamol 1000 mg	1	120	Risk Ratio (M‐H, Random, 95% CI)	1.43 [1.15, 1.78]
2 Proportion of patients with > 50% max pain relief (TOTPAR) over 2 hours Show forest plot	6	926	Risk Ratio (M‐H, Random, 95% CI)	1.29 [1.13, 1.46]

2.1 Ibuprofen 512 mg versus paracetamol 1000 mg	1	120	Risk Ratio (M‐H, Random, 95% CI)	1.28 [0.98, 1.67]
2.2 Ibuprofen 400 mg versus paracetamol 1000 mg	5	645	Risk Ratio (M‐H, Random, 95% CI)	1.30 [1.09, 1.55]
2.3 Ibuprofen 200 mg versus paracetamol 1000 mg	1	93	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.85, 1.41]
2.4 Ibuprofen 400 mg versus paracetamol 600 mg	1	68	Risk Ratio (M‐H, Random, 95% CI)	1.74 [0.96, 3.14]
3 Number of patients using rescue medication at 6 hours Show forest plot	5	823	Risk Ratio (M‐H, Random, 95% CI)	1.44 [1.26, 1.64]

3.1 Ibuprofen 200 mg versus paracetamol 1000 mg	1	93	Risk Ratio (M‐H, Random, 95% CI)	1.38 [0.94, 2.02]
3.2 Ibuprofen 400 mg versus paracetamol 1000 mg	4	542	Risk Ratio (M‐H, Random, 95% CI)	1.50 [1.25, 1.79]
3.3 Ibuprofen 512 mg versus paracetamol 1000 mg	1	120	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.86, 1.60]
3.4 Ibuprofen 400 mg versus paracetamol 600 mg	1	68	Risk Ratio (M‐H, Random, 95% CI)	1.93 [0.87, 4.30]
4 Number of patients using rescue medication at 8 hours Show forest plot	2	402	Risk Ratio (M‐H, Fixed, 95% CI)	2.02 [1.57, 2.60]

4.1 Ibuprofen 200 mg versus paracetamol 500 mg	1	75	Risk Ratio (M‐H, Fixed, 95% CI)	2.36 [1.31, 4.25]
4.2 Ibuprofen 400 mg versus paracetamol 500 mg	1	75	Risk Ratio (M‐H, Fixed, 95% CI)	2.77 [1.57, 4.89]
4.3 Ibuprofen 200 mg versus paracetamol 1000 mg	1	75	Risk Ratio (M‐H, Fixed, 95% CI)	1.87 [1.10, 3.17]
4.4 Ibuprofen 400 mg versus paracetamol 1000 mg	2	177	Risk Ratio (M‐H, Fixed, 95% CI)	1.66 [1.11, 2.48]

Comparison 1. Ibuprofen versus paracetamol

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Comparison 2. Combined (ibuprofen and paracetamol) versus single drugs

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Proportion of patients with > 50% max pain relief (TOTPAR) over 6 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 Paracetamol 1000 mg/ibuprofen 400 mg versus paracetamol 1000 mg or ibuprofen 400 mg	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Proportion of patients with > 50% max pain relief (TOTPAR) over 2 hours Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.1 Paracetamol 1000 mg/ibuprofen 400 mg versus paracetamol 1000 mg or ibuprofen 400 mg	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Number of patients using rescue medication at 8 hours Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 Paracetamol 1000 mg/ibuprofen 400 mg versus paracetamol 1000 mg or ibuprofen 400 mg	2	467	Risk Ratio (M‐H, Fixed, 95% CI)	1.60 [1.36, 1.88]

Comparison 2. Combined (ibuprofen and paracetamol) versus single drugs

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Ibuprofeno y paracetamol (acetaminofeno) para el alivio del dolor posterior a la extracción quirúrgica de la muela de juicio inferior

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