Malmstrom 2006.
Study characteristics | ||
Methods | Type: clinical Design: parallel Objective: to assess analgesic effect of intravenous lidocaine on pain following the removal of impacted third molars. Treatment duration: 1 hour Follow‐up duration (including treatment duration): 6 hours Washout between cross‐over periods: NA |
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Data | Country: USA Condition: pain after removal of third molars Number of people randomised: 10 to each placebo (40 in total to all study arms) Number of people analysed: 10 for active placebo and 9 for standard placebo |
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Comparisons | Active placebo: diphenhydramine (bolus of 10 mg, continuous infusion of 40 mg) Standard placebo: saline infusion Experimental intervention: likely matched intervention: lidocaine (1.25 mg/kg bolus and 2.75 mg/kg infusion). The fourth intervention arm was oral oxycodone/acetaminophen (10 mg/650 mg; matched by placebo tablets in the other arms) Administration: IV |
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Outcomes | Participant‐reported outcome: TOPAR1 and TOPAR6 (weighted total of pain relief scores over the first hour and the first 6 hours). Trial's own primary time point was TOPAR2, which was not the earliest post‐treatment time point. Observer‐reported outcome: none Harm outcome: number of participants with 1 or more adverse experiences. Paper also reports number of each particular side effect. Co‐intervention outcome: number of people requesting rescue medication, and median time to rescue medication (acetaminophen/hydrocodone 500/5 mg) |
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Terminology for active placebo | "Active placebo" a priori | |
Scores and unpleasantness of the active placebo | Adequacy: 2
Risk of therapeutic effect: 2 Unpleasant/neutral/pleasant: unpleasant |
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Funding and conflicts of interest | Industry funded. All 7 trial authors appear to be employed by Merck. | |
Notes | CIs were truncated at 0 for the lower bound; we recalculated and used the untruncated interval. | |
Risk of bias | ||
Item | Authors' judgement | Support for judgement |
Free from risk of bias arising from the randomisation process | Unclear | Computer‐generated schedule. No information on allocation concealment. Baseline differences do not suggest a problem. |
Free from risk of bias in selection of the reported result All outcomes | Unclear | No information. |