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Efficacy and safety of sufentanil sublingual tablet system in postoperative pain management: a systematic review and meta-analysis
  1. Pugazhenthan Thangaraju1,
  2. Shoban Babu Varthya2,
  3. Sajitha Venkatesan3,
  4. Thangaraju Tamilselvan4 and
  5. Surjit Singh2
  1. 1 Pharmacology, AIIMS Raipur, Raipur, India
  2. 2 Pharmacology, AIIMS Jodhpur, Jodhpur, India
  3. 3 Microbiology, AIIMS Raipur, Raipur, India
  4. 4 Pharmacology, SRM University, Gangtok, India
  1. Correspondence to Dr Surjit Singh, Pharmacology, AIIMS Jodphur, Jodhpur 342005, India; sehmby_ss{at}


Background Sufentanil sublingual tablet system (SSTS) is a recently approved formulation for postoperative pain management that has become popular due to its pharmacokinetic properties such as good bioavailability, rapid attainment of equilibrium and elimination without any metabolites, along with its pharmacodynamic properties such as rapid onset and effective pain reduction. It is also relatively well tolerated by patients.

Objective This is a quantitative analysis of the efficacy and safety of SSTS in patients with moderate to severe postoperative pain.

Design This is a systematic review and meta-analysis. Databases such as Cochrane Library, MEDLINE and EMBASE were searched for eligible articles.

Settings Randomised controlled trials published after 2000 in English language and which assessed at least one of the outcome measures of interest with pain intensity difference between 12 hours and a maximum of 96 hours.

Participants Adults with moderate to severe postoperative pain and taking SSTS for pain management.

Methods Data were analysed using Review Manager (RevMan) V.5.3. Risk of bias (RoB) assessment was done using RoB-2 scale, and overall grading of evidence of each outcome was done using GRADEpro Guideline Development Tool.

Results Analysis of SSTS versus control indicates a statistically significant reduction in summed pain intensity difference at 12 hours (mean difference (MD)=−12.33 (95% CI −15.5 to −9.17), p<0.00001), summed pain intensity difference at 48 hours (MD=−43.57 (95% CI −58.65 to −28.48), p<0.00001), time-weighted total pain relief over 12 hours (MD=−4.77 (95% CI −6.28 to −3.27), p<0.00001) and pain intensity difference (MD=–0.73 (95% CI −1.00 to −0.46), p<0.00001) with SSTS, alongside high quality of evidence. Success of treatment as assessed by Patient Global Assessment (OR=4.01 (95% CI 2.74 to 5.89), p<0.00001) and Healthcare Professional Global Assessment (OR=4.46 (95% CI 3.03 to 6.56), p<0.00001) scoring at 72 hours was observed in a significantly high number of individuals using SSTS, with high quality of evidence. There was no difference in adverse events except for dizziness (RR=1.90, 95% CI 1.02 to 3.52). There was a significantly higher number of total adverse events in orthopaedic surgery in the SSTS group than in the comparator.

Conclusion SSTS is effective in postoperative pain management in patients with moderate to severe pain. It also has good tolerability and high patient satisfaction.

PROSPERO registration number CRD42018115458.

  • pain
  • pharmacology
  • supportive care

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  • PT and SBV are joint first authors.

  • PT and SS contributed equally.

  • Correction notice This article has been updated since it was first published. The article type has been changed to Systematic review.

  • Contributors PT: conceptualisation, methodology. SBV: methodology, data curation, writing-original draft preparation. SV: visualisation, investigation. TT: supervision. SS: methodology, data curation, writing-reviewing and editing.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.