| Methods |
Random allocation (method not reported). Double‐blind stated. 8/58 failed to comply with protocol and were excluded. Groups similar on demographics and drug use. |
| Participants |
58 opioid dependent by ICD‐10 and DSM‐IV. Eight excluded for failure to comply with study protocol and incomplete data collection. Group sizes (1) 22 (2) 28. Use of long‐acting opioids an exclusion criterion. Mean age 23, 84% male, mean 4 years of opiate abuse, mean 2.3 previous medical detoxifications. |
| Interventions |
Stabilised on morphine 2 days (inpatient). Naloxone 1.6mg iv, 0.8mg/h iv infusion, naltrexone 100mg via oro‐gastric tube under isoflurane anaesthesia with intubation. Prior to opioid antagonist treated with (1) ketamine, subanaesthetic, 0.5mg/kg/h or (2) placebo ‐ normal saline. Inpatient treatment, general hospital. |
| Outcomes |
Mean arterial pressure, heart rate, opiate withdrawal during anaesthesia. Number entering post‐detoxification treatment. Status at 4 month follow‐up. |
| Notes |
Withdrawal severity by modified Wang scale during anaesthesia, and by Subjective and Objective Withdrawal Scales following anaesthesia. Country: Lithuania |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Quote: "Patients were randomly assigned ... on the day of procedure." Method of sequence generation not reported. |
| Allocation concealment? |
Unclear risk |
Not reported. |
| Blinding?
Subjective outcomes ‐ intensity of withdrawal, adverse effects |
Unclear risk |
Double‐blind stated and placebo used, but unclear whether treating staff were blind. |
| Blinding?
Objective outcomes ‐ duration of treatment, completion of treatment |
Low risk |
Double‐blind stated and these outcomes considered unlikely to be affected by knowledge of treatment method. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Eight participants excluded prior to randomisation. No dropout during detoxification; loss to follow‐up after detoxification similar for the two groups. |
| Free of selective reporting? |
Low risk |
None apparent |
| Free of other bias? |
Low risk |
None apparent |
| Other bias: Selection of comparison cohort |
Low risk |
Experimental and comparison groups drawn from same population. |
| Other bias: Comparability of cohorts |
Low risk |
Groups similar on demographics and drug use. |
| Other bias: Representativeness of exposed cohort |
Unclear risk |
Means of recruiting participant and source population not reported. |
| Other bias: Ascertainment of exposure |
Low risk |
Data collection established by study protocol. |
