Gupta 2006.
| Study characteristics | ||
| Methods | RCT. 3 arms. | |
| Participants | Number of children: 75 (25 in each group) Sex of children: 44 M, 31 F Age range of children: 6 ‐ 12 years Mean age of children: 8.9 ± 2.1 years (distraction); 8.6 ± 2.4 years (balloon inflation); 8.8 ± 2.1 years (control) Needle procedure: venepuncture Diagnosis of child: ASA physical status I ‐ II, undergoing elective surgery Inclusion criteria: ASA physical status I ‐ II, undergoing elective surgery Exclusion criteria: children with delayed milestones, cardiac or neurological impairment, or failure to cannulate on the first attempt Setting: Not specified, India |
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| Interventions | 1. Distraction group: Children compressed and released a rubber ball in the palm of their hand which was not to be cannulated. 2. Balloon group: Children were asked to inflate a balloon at least for 20 seconds before initiation of the venipuncture. The cannula insertion was performed during the act of forceful expiration. 3. Control group: No rubber ball or balloon inflation |
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| Outcomes | Pain measure:
Adverse events: none mentioned |
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| Notes | Study dates: January 1, 2005 to July 31, 2005 Funding: none stated Conflicts of interest: none declared |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "consecutive pediatric patients were randomized with a computer generated table of random numbers" p.1372 Par 3 |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgment of 'low' or 'high' risk |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of self‐report outcome assessment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
| Selective reporting (reporting bias) | High risk | One or more outcomes reported incompletely for inclusion in meta‐analysis |
| Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists |