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. 2021 Jun 14;2021(6):CD012978. doi: 10.1002/14651858.CD012978.pub2

Abanto 2014.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 60
Country: Peru
Setting: dental clinic
Dates conducted: November 2013 to July 2014
Postoperative opioid used and delivery: none
Pain score collection: researcher
Concurrent postoperative analgesics: paracetamol or NSAID
Participants Inclusion criteria
  1. ASA 1

  2. Aged 18 to 45 years old

  3. Complete primary education

  4. Undergoing simple dental extraction for dental caries and asymptomatic at the time of extraction with a previous history of extraction


Exclusion criteria
  1. Refused study participation

  2. Contraindication to extraction or study drugs

  3. Pregnancy or breast‐feeding

  4. Patients receiving anaesthesia, sedatives, paracetamol, NSAIDs, tricyclic antidepressants, opioids, corticosteroids, anticonvulsants, phenothiazines, alcohol or caffeine 48 hours before the extraction

  5. Intellectual disability

  6. Procedure could not be performed

  7. Exceeded two tubes of anaesthetic (> 3.6 mL) to achieve adequate anaesthesia

  8. Pain more than 70 mm (on a 100 mm VAS) pre‐extraction

  9. Procedures exceeded 20 minutes

  10. Participants who did not fill in the measuring instrument correctly

  11. Participants who did not comply with the instructions, abandoned the study, did not attend postoperative control or those who presented with any of the following post‐extraction complications: haemorrhage, infection, alveolitis, soft tissue lesions, bone or adjacent parts

Interventions Group Prophylactic (30 participants): naproxen sodium 550 mg PO 30 minutes before the procedure, then every 12 hours for 4 doses
Group Continuous (30 participants): naproxen sodium 550 mg PO 20 minutes after the procedure, then every 12 hours for 4 doses
Outcomes
  1. Postoperative pain (0‐100 mm VAS at 1, 8 and 24 hours)

  2. Adverse effects (no details given)

Notes Funding: not reported
Declarations of interest: not reported
Authors contacted: no
Other: article in Spanish. Unpublished thesis.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Unclear details. Quote: "Patients were randomly assigned".
Allocation concealment (selection bias) Unclear risk No mention
Blinding of participants and personnel (performance bias)
All outcomes High risk No mention of double‐dummy placebo. Quote: "Naproxen sodium 550 mg was administered orally 30 minutes before the procedure, then every 12 hours until the 4 doses".
Blinding of outcome assessment (detection bias)
All outcomes High risk Likely unblinded from above information
Incomplete outcome data (attrition bias)
All outcomes Low risk Three excluded for alveolitis unlikely to bias results as this would cause confounding from increased pain. Quote: "Three people were eliminated by alveolitis".
Selective reporting (reporting bias) Unclear risk No registration or protocol. Unpublished thesis
Other bias Unclear risk No detailed information on baseline characteristics