Dini 1986.

Methods	Design: Randomised parallel‐group trial Year: Not reported Country: Italy
Participants	Patients: Patients divided into two group: Group Tablet and group Vial (fluid). Within each of these groups patients were allocated to treatment with either buprenorphine or pentazocine: Group Tablet: 9 males/12 females; mean age = 59 years; cancer type: breast (6), prostate (2), rectal (3), oral cavity (3), bladder (1), uterine (1), laryngeal (1), hypopharynx (1), lung (1), ovarian (1), anal (1). 11 patients were treated with buprenorphine and 10 with pentazocine. 11 patients were treated with buprenorphine and 10 with pentazocine. Group Vial (fluid): 12 males/9 females; mean age = 59 years; cancer type: breast (4), gastric (1), rectal (3), lung (3), bladder (1), transverse colon (1), sigmoid colon (1), papiloma of nasal cavity (1), parotid (1), renal (1), uterine (1), sarcoma of the thigh (1), undetermined (2). 11 patients were treated with buprenorphine and 10 with pentazocine. Inclusion criteria: 42 patients aged > 18 years with pain of moderate‐severe intensity of neoplastic origin was selected by/from The Center for Pain Management at the National Institute of Cancer Research. Exclusion criteria: Severe renal or hepatic impairment, severe respiratory failure, previous treatment with agonist analgesics, intracranial hypertension, mental confusion, pregnancy/lactation.
Interventions	Buprenorphine tablets: Drug: Buprenorphine SL tablets 0.2 mg. Dose/dosing: 1 to 2 tablets of 0.2 mg administered every 6 to 8 hours depending on need. Formulation: SL. Route of administration: Oral. Length of treatment: 7 days. Titration schedule: No information reported. Rescue medication: No information provided. Other medication: No information provided. Buprenorphine vials/fluid: Drug: Vials 0.3 mg. Dose/dosing: 1 vial of 0.3 mg administered at a dose of 1 to 3 vials a day, depending on the severity of the case (mean daily dose was 1.7 vials). Formulation: Oral. Route of administration: Oral. Length of treatment: 7 days. Titration schedule: No information reported. Rescue medication: No information provided. Other medication: No information provided. Pentazocine tablets: Drug: Tablets 50 mg. Dose/dosing: 1 tablet of 50 mg administered at a dose of 3 tablets a day. Formulation: Oral. Route of administration: Oral. Length of treatment: 7 days. Titration schedule: No information reported. Rescue medication: No information provided. Other medication: No information provided. Pentazocine vials/fluid: Drug: Vials 30 mg Dose/dosing: 1 vial of 30 mg administered at a dose of 1 to 3 vials a day (mean daily dose was 2.2 vials). Formulation: Oral. Route of administration: Oral. Length of treatment: 7 days. Titration schedule: No information reported. Rescue medication: No information provided. Other medication: No information provided.
Outcomes	Pain intensity: Assessed by patients(?) daily on a 6‐point categorical scale: 0 = no pain, 1 = mild pain, 2.5 = moderate pain, 5 = some considerable pain, 7.5= strong pain, 10 = unbearable pain. Number of hours slept, number of hours pain free, and number of hours assessed as any of the pain categories above. "Daily integrated intensity and duration of pain score" calculated by (1) calculating the exact number of hours of pain, (2) multiplying the number of hours by the values corresponding to the intensity of the pain experienced, (3) summing the products, and (4) dividing the total by the number of days of treatment. Number of hours spent upright, and supine (whether sleeping or not). Effectiveness of treatment: Assessed by patients(?) on a 5‐point categorical scale: excellent, good, fair, poor, nothing. Tolerability of treatment: Assessed by patients(?) on a 4‐point categorical scale: excellent, good, fair, poor. Side effects.
Notes	Study free of commercial funding? Unclear, the information reported for the author affiliations is ambiguous and may include the manufacturer of buprenorphine. Groups comparable at baseline? Unclear, very limited information reported. ITT analyses undertaken? It is not clear whether the analyses were conducted as ITT. This study is published in Italian and lay‐translated by MSH.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information other than that the patients were randomised is reported.
Allocation concealment (selection bias)	Unclear risk	See cell above.
Blinding of participants and personnel (performance bias) Pain	Unclear risk	No information reported.
Blinding of participants and personnel (performance bias) Adverse events	Unclear risk	See cell above.
Blinding of outcome assessment (detection bias) Pain	Unclear risk	See cell above.
Blinding of outcome assessment (detection bias) Adverse events	Unclear risk	See cell above.
Incomplete outcome data (attrition bias) Pain	Unclear risk	It is unclear whether any data are missing.
Incomplete outcome data (attrition bias) Adverse events	Unclear risk	See cell above.
Selective reporting (reporting bias)	Low risk	The main expected outcomes appear to be reported.
Other bias	Unclear risk	It is unclear whether the study is subject to high risk of other types of bias.
Were the patients adequately titrated?	Unclear risk	No information reported.
For cross‐over trials: Are data available for both time periods?	Unclear risk	NA.