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Single dose intravenous diclofenac for acute postoperative pain in adults

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Appendices

Appendix 1. Glossary

Categorical rating scale: the most common are the four‐category scale for pain intensity (none, mild, moderate, and severe) and the five‐category scale for pain relief (none, slight, moderate, good or lots, and complete). For analysis, numbers are given to the verbal categories (for pain intensity, none = 0, mild = 1, moderate = 2, and severe = 3, and for relief, none = 0, slight = 1, moderate = 2, good or lots = 3, and complete = 4). Data from different participants are then combined to produce means (rarely medians) and measures of dispersion (usually standard errors of means). The validity of converting categories into numerical scores is checked by comparison with concurrent visual analog scale measurements. Good correlation is found, especially between pain relief scales using cross‐modality matching techniques. Results are usually reported as continuous data, mean or median pain relief or intensity. Few studies present results as discrete data, giving the number of participants who report a certain level of pain intensity or relief at any given assessment point. The main advantages of the categorical scales are that they are quick and simple. The small number of descriptors may force the scorer to choose a particular category when none describes the pain satisfactorily.

Visual analog scale (VAS): for pain intensity, lines with left end labeled 'no pain' and right end labeled 'worst pain imaginable', and for pain relief lines with left end labeled 'no relief of pain' and right end labeled 'complete relief of pain', seem to overcome the limitation of forcing participant descriptors into particular categories. Participants mark the line at the point that corresponds to their pain or pain relief. The scores are obtained by measuring the distance between the 'no relief of pain' end and the participant's mark, usually in millimeters. The main advantages of VAS are that they are simple and quick to score, avoid imprecise descriptive terms, and provide many points from which to choose. More concentration and co‐ordination are needed, which can be difficult postoperatively or with neurological disorders.

Total pain relief (TOTPAR): TOTPAR is calculated as the sum of pain relief scores over a period of time. If a participant had complete pain relief (as measured on a 5‐point categorical scale) immediately after taking an analgesic, and maintained that level of pain relief for six hours, they would have a six‐hour TOTPAR of the maximum of 24 (6 x 4). Differences between pain relief values at the start and end of a measurement period are dealt with by the trapezoidal rule. This is a simple method that approximately calculates the definite integral of the area under the pain relief curve by calculating the sum of the areas of several trapezoids that together closely approximate to the area under the curve.

Summed pain intensity difference (SPID): SPID is calculated as the sum of the differences between the pain scores and baseline pain score over a period of time. Differences between pain intensity values at the start and end of a measurement period are dealt with by the trapezoidal rule.

VAS TOTPAR and VAS SPID are visual analog versions of TOTPAR and SPID.

See 'Measuring pain' in Bandolier's Little Book of Pain (Moore 2003).

Appendix 2. MEDLINE search strategy

1. (diclofenac or dichlofenal or diclonate or feloran or novapirina or orthofen or orthophen or voltaren or voltarol or ortofen or dyloject).tw.
2. Diclofenac/
3. 1 or 2
4. exp Pain, Postoperative/
5. pain.tw.
6. 4 or 5
7. randomized controlled trial.pt.
8. controlled clinical trial.pt.
9. randomized.ab.
10. placebo.ab.
11. drug therapy.fs.
12. randomly.ab.
13. trial.ab.
14. groups.ab.
15. 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14
16. exp animals/ not humans.sh.
17. 15 not 16
18. 3 and 6 and 17

Appendix 3. GRADE: criteria for assigning grade of evidence

The GRADE system uses the following criteria for assigning a quality level to a body of evidence (Chapter 12, Higgins 2011).

  • High: randomized trials; or double‐upgraded observational studies.

  • Moderate: downgraded randomized trials; or upgraded observational studies.

  • Low: double‐downgraded randomized trials; or observational studies.

  • Very low: triple‐downgraded randomized trials; or downgraded observational studies; or case series/case reports.

Factors that may decrease the quality level of a body of evidence are:

  • limitations in the design and implementation of available studies suggesting high likelihood of bias;

  • indirectness of evidence (indirect population, intervention, control, outcomes);

  • unexplained heterogeneity or inconsistency of results (including problems with subgroup analyses);

  • imprecision of results (wide confidence intervals);

  • high probability of publication bias.

Factors that may increase the quality level of a body of evidence are:

  • large magnitude of effect;

  • all plausible confounding would reduce a demonstrated effect or suggest a spurious effect when results show no effect;

  • dose‐response gradient.