Figure 4: Treatment effects reported in individual studies at time points from 3 (3 h) to 12hours (12h) The blue dots signify treatment effects >10-points which are considered clinically worthwhile. Note Quiding et al., 1992 [53]; results are for average pain over 8 hours following 1st dose and 6th dose. The 6th dose was measured from 24 - 32hours. * Study reported the mean pain intensity difference over the follow up period specified. ** Study used a multiple dose regimen. Table 2: Characteristics of included studies Study Setting / Indication Mean age of Participant Intervention Control Outcome Follow Up Country participants Characteristics [Randomised, double Measure period (post (number blind, parallel group] ingestion) entered) Pain Trials Ahlstrom Stockholm Surgical removal of I (A): 31 I (A): 44 I (A): paracetamol Placebo 0-10 VAS 12 h 1985 Sweden an impacted I (B): 29 I (B): 43 1000 mg + codeine 60 wisdom P (C): 27 Placebo: 85 mg P (D): 28 I (B): paracetamol 500 F: 82 mg + codeine 30 mg M: 90 A second dose could be taken 1985 Nottingham Post episiotomy I: 23.1 I: 46 single dose study Placebo 9 point pain 8 h England pain P: 22.7 P: 47 Ibuprofen 400 mg + rating scale i.e. codeine 30 mg n=46 0-8 Frame 1986 Queensway Removal of an I (C): 23.55 I (C): 33 single dose study Placebo 9 point pain 5 h Birmingham impacted I (D):25.09 I (D):33 I (C): 33 ibuprofen rating scale i.e. mandibular third I (E): 23.70 I (E): 33 200 mg + codeine 15 0-8 molar tooth P (A): 23.55 P (A): 33 mg I (D):33 ibuprofen 400 mg + codeine 30 mg I (E): 33 ibuprofen 800 mg + codeine 60 mg P (A): 33
Figure 4: Treatment effects reported in individual studies at time points from 3 (3 h) to 12hours (12h) The blue dots signify treatment effects >10-points which are considered clinically worthwhile. Note Quiding et al., 1992 [53]; results are for average pain over 8 hours following 1st dose and 6th dose. The 6th dose was measured from 24 - 32hours. * Study reported the mean pain intensity difference over the follow up period specified. ** Study used a multiple dose regimen. Table 2: Characteristics of included studies Study Setting / Country Indication Mean age of participants Participant Characteristics (number entered) Intervention [Randomised, double blind, parallel group] Control Outcome Measure Follow Up period (post ingestion) Pain Trials Ahlstrom 1985 Stockholm Sweden Surgical removal of an impacted wisdom I (A): 31 I (B): 29 P (C): 27 P (D): 28 I (A): 44 I (B): 43 Placebo: 85 F: 82 M: 90 I (A): paracetamol 1000 mg + codeine 60 mg I (B): paracetamol 500 mg + codeine 30 mg A second dose could be taken Placebo 0-10 VAS 12 h 1985 Nottingham England Post episiotomy pain I: 23.1 P: 22.7 I: 46 P: 47 single dose study Ibuprofen 400 mg + codeine 30 mg n=46 Placebo 9 point pain rating scale i.e. 0-8 8 h Frame 1986 Queensway Birmingham Removal of an impacted mandibular third molar tooth I (C): 23.55 I (D):25.09 I (E): 23.70 P (A): 23.55 I (C): 33 I (D):33 I (E): 33 P (A): 33 single dose study I (C): 33 ibuprofen 200 mg + codeine 15 mg I (D):33 ibuprofen 400 mg + codeine 30 mg I (E): 33 ibuprofen 800 mg + codeine 60 mg P (A): 33 Placebo 9 point pain rating scale i.e. 0-8 5 h
review-efficacy-and-safety-over-counter-codeine-combination-medicines.docx