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. 2014 Mar 28;2014(3):CD008261. doi: 10.1002/14651858.CD008261.pub2

Nesek‐Adam 2012.

Methods Randomised clinical trial.
Participants Country: Croatia.
Number randomised: 80.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 80.
Mean age: 51 years.
Females: 58 (72.5%).
Inclusion criteria:

  1. Aged 18 to 70 years.

  2. Scheduled for laparoscopic cholecystectomy.

  3. ASA physical status I or II.


Exclusion criteria:

  1. Pre‐existing neurological or psychiatric disease.

  2. Chronic pain syndrome.

  3. History of peptic ulceration, hepatic, and renal insufficiency.

  4. Pregnancy.

  5. Receiving regular opioids or drugs with any analgesic properties in 24 h before surgery.

  6. Operation for acute cholecystitis.

  7. Operation converted to an open procedure.
Interventions Participants were randomly assigned to 1 of 4 groups.
 Group 1: diclofenac 1 mg/kg IV 20 min before induction (n = 20).
 Group 2: saline 100 mL IV 20 min before induction (n = 20).
 Group 3: same as group 1 with ketamine IV as co‐intervention (n = 20).
 Group 4: same as group 2 with ketamine IV as co‐intervention (n = 20).
Outcomes Drug‐related serious adverse events.
Notes Attempts were made to contact authors in August 2013.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Computer‐generated table of random numbers".
Allocation concealment (selection bias) Unclear risk Quote: "An envelope containing group assignment was prepared, sealed, and numbered for each patient".
Comment: Further details were not available.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "On the morning of surgery, anesthesia technician opened the envelope and prepared completely identical syringes and infusion that were labeled "infusion" and "skin bolus" in equal volume to make the study double blind".
Comment: Further details were not available.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: This information was not available.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: This information was not available.
Selective reporting (reporting bias) High risk Comment: Mortality and morbidity were not reported.
For‐profit bias Unclear risk Comment: This information was not available.