Pickworth 1993.

Methods	Open‐label quasi‐randomised controlled trial
Participants	Baseline characteristics Number randomised: 92 participants Number analysed: 83 participants Sucralfate Age (years; mean (SD)): 26.8 (‐) Number of participants (n): 39 Gender (male/female; n): ‐ Ranitidine Age (years; mean (SD)): 27.3 (‐) Number of participants (n): 44 Gender (male/female; n): ‐ Inclusion criteria Multiple injured persons Age 15 to 42 years Admitted to the 15‐bed surgical intensive care unit Participants who were endotracheally intubated within 24 hours of admission NG tube was required for drug administration Exclusion criteria Inclusion in another study Transferred from another hospital > 24 hours after injury Active GI bleeding Having taken antacid, histamine‐2 blockers or sucralfate up to 48 hours before admission Spinal cord injury Treatment with high dose of methylprednisolone Baseline imbalances: Quote: "There were no significant differences between the two groups in demographic data, trauma score, revised trauma score, Injury severity score and APACHE II score"
Interventions	Sucralfate Dose (total/d): 4 g Duration of treatment (days): until initiation of enteral feeding, extubation, placement of tracheotomy, transfer from ICU, or death Route: NG tube Intervention: sucralfate 1 g dissolved in 15 mL of sterile water, administered through NG tube every 6 hours Concomitant medications: Antibiotics were given, and most participants in both arms were given cefazoline (n = 22) Ranitidine Dose (total/d): 200 mg Duration of treatment (days): until initiation of enteral feeding, extubation, placement of tracheotomy, transfer from ICU, or death Route: IV Intervention: ranitidine 50 mg intravenously every 6 hours Concomitant medications: Antibiotics were given, and most participants in both arms were given cefazoline (n = 24) Adherence to regimen: Of the 92 participants, 9 were subsequently excluded for protocol breaks: 4 patients because they did not meet age criteria, 3 patients because admitting chest radiographic films were abnormal, and 2 patients because of inadvertent extubation Duration of trial: January 1989 to August 1991 Duration of follow‐up: All patients were followed until hospital discharge or death
Outcomes	Outcomes sought in review and reported in trial Primary outcomes Incidence of nosocomial pneumonia based on new infiltrate in the chest roentgenogram and 3 of the following 4 criteria: rectal temperature > 38.5°C, white blood cell count > 10,000 cells/mm³, positive sputum culture obtained by leukins trap, or sputum sample obtained by leukins trap with gram stain containing many white blood cells (> 25 white blood cells, < 10 epithelial cells, and numerous bacteria per high‐power field) Secondary outcomes Significant GI bleeding (no episodes of significant upper GI bleeding) All‐cause mortality in ICU Blood transfusions (no participants required transfusions) Duration of intubation (data for each intervention not provided separately, SD for each intervention not provided) Duration of ICU stay (data for each intervention not provided separately, SD for each intervention not provided) Outcomes sought but not reported in trial report Adverse drug reactions Outcomes reported in report but not used in review Duration of hospital stay (SD not provided)
Notes	Setting: SICU, Grant Medical Centre, Columbus, Ohio, USA Source of funding: Quote: "Supported in part by a  Roche Hospital Pharmacy Research Grant" Conflicts of interest: ‐ Ethics approval: Study was approved and monitored by the Institutional Review Board Informed consent: Consent for therapy was considered consent for study inclusion, and specific informed consent was waived by the Institutional Review Board Clinical trials registration: ‐ Sample size calculation: Quote: "The present study was designed to produce a power of 90% with a 30% difference in pneumonia rates between the groups"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "Randomisation occurred by the use of computer generated random number table. Odd numbered patients received ranitidine 50 mg every 6 hours and even numbered patients received sucralfate 1 g dissolved in 15 mL of sterile water ..." Comment: Method adopted to obtain random sequence generation is clearly mentioned in the study report but is not adequate to generate a random sequence
Allocation concealment (selection bias)	Unclear risk	Comment: not clearly mentioned in the study report
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: Different modes of administering study drugs and absence of placebo would not have made it possible to blind the study
Blinding (detection bias) Clinically important upper GI bleeding	Low risk	Comment: Study report is unclear on blinding of outcome assessors. However GI bleeding was an objective outcome detected as per the definition in the study protocol
Blinding (detection bias) Nosocomial pneumonia	Low risk	Comment: Study report is unclear on blinding of outcome assessors. However, nosocomial pneumonia was detected as per the definition in the study protocol
Blinding of outcome assessment (detection bias) Adverse reactions of interventions	Unclear risk	Comment: Study report is unclear on blinding of outcome assessors. However, all other outcomes were objective in nature
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Nine patients were subsequently excluded for protocol breaks: four patients because they did not meet the age criteria, three patients because admitting chest radiographic films were abnormal and two patients had inadvertent extubation. These patients had been evenly distributed between study groups and none of the excluded patients developed pneumonia" Comment: Although 92 participants were enrolled in the study, only 83 were analysed. The interventional arms to which these 9 participants were randomised are not clearly mentioned in the study report, but it does say that participants were evenly distributed between study groups, and none of them developed pneumonia. Therefore the likelihood of attrition bias is minimal
Selective reporting (reporting bias)	Low risk	Comment: All intended outcomes were part of the final analysis
Other bias	Low risk	Comment: Study was supported in part by a  Roche Hospital Pharmacy Research Grant. However, the role of the sponsor in the conduct and reporting of the trial is unclear. No other sources of bias suspected