| Methods |
Randomized, double‐blinded, controlled trial |
| Participants |
ASA I‐II patients, aged 2‐8 years, undergoing ventriculoperitoneal shunt insertion
Forty‐five (45) children: 15 in each of two clonidine groups; 15 in midazolam group
Excluded any children who refused or spat out the medication
Other exclusion criteria: abnormal liver function, renal and mental disease |
| Interventions |
Group C2: clonidine 2 μg/kg, orally
Group C4: clonidine 4 μg/kg, orally
Group M: midazolam 0.5 mg/kg, orally
All medications given in 5 ml of syrup, 60 min pre‐induction |
| Outcomes |
Main outcomes of study were: preoperative sedation, mask acceptance, separation from parents; also included postoperative analgesia, haemodynamic status and adverse effects (hypotension, bradycardia, respiratory depression, nausea/vomiting, shivering)
Pain is reported as whether or not rescue analgesia was required postoperatively |
| Notes |
Rescue analgesia was given in the cases of child complaints of pain, frequent crying, or dysphoria after operation; analgesia was via a rectal loading dose of paracetamol of 30‐40 mg/kg |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Trial is described as "Randomized" but no description of this given |
| Allocation concealment (selection bias) |
Unclear risk |
No details given |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Unclear as to whether the person responsible for the patient's care, or the patient, were blinded. Outcome assessor appears to have been blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Children who spat out drug were excluded but no details on frequency of this |
| Selective reporting (reporting bias) |
Unclear risk |
None evident |
| Other bias |
Low risk |
No other obvious source of bias; control and experimental patient characteristics appear similar |
