METHODOLOGICAL QUALITY OF STUDIES: Ketamine

StudySequence GenerationAllocation ConcealmentBlindingITT and Power CalculationAttrition detailsBaseline Comparable
Acworth 2001 (Ref ID: 815)Adequate- computer or calculator generated sequence.; Drug route precluded double blinding but the doctor and nurse responsible for scoring sedation level were not present during drug dministration and were blinded to allocation by use of dummy armboard applied to children receiving the intranasal medication.Patient: no single blind trial.

Outcome assessor: Yes.
ITT: Yes, all followed.

Power calculation: Yes; A total of 50 patients (25 in each group) was initially identified as required to give 90% power to detect a mean difference in the Sedation Scores between groups of 1.0 (SD=1.0) at 5% significance level.
Yes, all completed intervention.Yes; There were no significant differences found between treatment groups with regard to sex, age, weight, procdure type, length or site of laceration, duration of procedure.
Erden 2009 (Ref ID: 4356)Adequate- computer or calculator generated sequence.Adequate- Third party cluster: third party had no knowledge.Patient: yes double blind trial.

Outcome assessor: Yes.
ITT: Yes, all followed.

Power calculation: Not stated; Power calculation not described ; sample size 113.
Yes, all completed intervention.Yes mainly.
Godambe 2003 (Ref ID: 630)Inadequate; odd or even day assignment.Inadequate- schedule known in advance, birthdate, case recore.Patient: yes double blind trial.

Outcome assessor: Yes; patient, parent and assessor were blinded.
ITT: Yes, all included in analysis, no details; all patients included in analyses.

Power calculation: Not stated.
Yes, all completed intervention.Yes mainly; patients in each group did nto differ in age, sex, rac, weight NPO time, use of opioid premedication and type of injury.
Kennedy 1998 (Ref ID: 1014)Partial- random permuted blocks; subjects were stratified acording to initial parental choice to remain in the room or not during reduction. Subjects were randomly assigned in blocks of 20 within strata to receive fentanyl or ketamine. A random number generator used.Adequate- Third party cluster: third party had no knowledge; two trained independent observers.Patient: not stated.

Outcome assessor: Partial; two trained observers were blinded to study purpose and design reviewed the videotape of each study. Unable to blind sedators.
ITT: Yes, all followed.

Power calculation: Yes; calculations based on OSBD. A sample of 40 required to detect a change in the mean of 1.05.
Yes, all completed intervention.Yes mainly; FM and KM groups did not differ in mean age, weight, gender, race, ASA class time from last oral intake, fracture location or presedation medications.
Kriwanek 2006 (Ref ID: 206)Adequate- computer or calculator generated sequence; computer generated randomization table in balanced blocks of 10.Not stated.Patient: no not blinded.

Outcome assessor: No; interventions differed in delivery method and blinding not possible.
ITT: Yes, all followed; all were followed for procedural outcomes and CHEOPS.

Power calculation: Yes; a sample size of 4=34 patients was required to detect a 2 point difference in the CHEOPS scale between the 2 groups, accepting a type I error of 0.05 and a power of 80%.
Yes, all completed intervention; satisfaction scores are not reported as 2 patients in the ABRA group were lost to follow up and 1 parent could not be contacted. Therefore sample size fell below 20.Yes mainly; the 2 groups were similar with respect to age, sex, types of fracture, narcotic analgesia received and anxiolytic dose of midazolam administered.
Lucas Da Silva 2007 (Ref ID: 153)Adequate- random numbers table or satistical table; random number generator.Adequate- sequentially numbered, opaque, sealed envelopes; maintained in sealed opaque envelopes.Patient: no not blinded.

Outcome assessor: No; double blinding was deemed impractical because of different dosing algorithms of the drugs used and because medications ued present clincially distinuishable effects.
ITT: Yes, all included in analysis, no details.

Power calculation: No.
Yes, all completed intervention.Yes mainly; there were no differences between the groups regarding age, weight, risk classification (ASA) and final sedation score.
Luhmann 2006 (Ref ID: 220)Adequate- computer or calculator generated sequence.Adequate- independent third party: allocates interventions & retains schedule/code.Patient: no not blinded - nature of intervention: different routes of administration.

Outcome assessor: Yes.
ITT: Yes, all followed; 6 protocol failures: one subject in the NO group was inadequately sedated and then received IV ketamine. Five subjects randomly assigned to receive K/M required more than the study dose of 1mg/kg; these were analyzed according to ITT methodology.

Power calculation: Yes; to achieve statistical power of 0.80 and a significance level of 0.05, a sample size of 50 per group or a total of 100 patients was needed.
Yes, all completed intervention.Yes mainly; the two groups were similar with regard to age, gender, race, ASA class, fracture location and baseline Procedure Behavior Checklist (PBCL).
Roback 2006 (Ref ID: 212)Adequate- computer or calculator generated sequence.Partial- third party cluster: unclear what third party knew; sham IV was placed in patients receiving IM ketamine.Patient: no single blind trial.

Outcome assessor: Yes.
ITT: Yes, all followed; 5 protocol violations (randomised to IM but received IV. Analyzed in IM group).

Power calculation: Not stated.
Unclear or Not stated.Not stated.
Tosun 2007 (Ref ID: 97)Unclear / not stated.Patial- not met all requirements:serially numbered/identical/allocate d sequentially; only ‘sealed envelopes’ described.Patient: yes double blind trial.

Outcome assessor: Yes.
ITT: Yes, all followed.

Power calculation: Not stated.
Yes, all completed intervention.Yes; there were no statistically significant differences between groups with respect to age, weight, sex.

From: Appendix D, Evidence Tables

Cover of Sedation in Children and Young People
Sedation in Children and Young People: Sedation for Diagnostic and Therapeutic Procedures in Children and Young People [Internet].
NICE Clinical Guidelines, No. 112.
National Clinical Guideline Centre (UK).
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