Less IS less: a randomised controlled trial comparing cautious and rapid nalbuphine dosing regimens

Woollard, Malcolm

doi:10.1136/emj.2004.014324

Cited by 13 publications

(9 citation statements)

References 12 publications

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“…Four pre-hospital controlled-trials investigating general trauma were conducted in the UK NHS. 100,[133][134][135] No pre-hospital trials concerning head-injury, conducted in the UK, could be identified. The remaining 11 studies were conducted in the USA, [136][137][138][139] (Table 25) summarising the appraisal of the four trials conducted in the UK NHS, upon which the discussion will focus, is presented below (the complete appraisal tables can be found in Appendix E (see Critical Appraisal tables).…”

Section: Resultsmentioning

confidence: 99%

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The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

Lecky

Russell

Fuller

et al. 2016

Health Technol Assess

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BackgroundReconfiguration of trauma services, with direct transport of traumatic brain injury (TBI) patients to neuroscience centres (NCs), bypassing non-specialist acute hospitals (NSAHs), could potentially improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) and the difficulties in reliably identifying TBI at scene may make this practice deleterious compared with selective secondary transfer from nearest NSAH to NC. National Institute for Health and Care Excellence guidance and systematic reviews suggested equipoise and poor-quality evidence – with regard to ‘early neurosurgery’ in this cohort – which we sought to address.MethodsPilot cluster randomised controlled trial of bypass to NC conducted in two ambulance services with the ambulance station (n = 74) as unit of cluster [Lancashire/Cumbria in the North West Ambulance Service (NWAS) and the North East Ambulance Service (NEAS)]. Adult patients with signs of isolated TBI [Glasgow Coma Scale (GCS) score of < 13 in NWAS, GCS score of < 14 in NEAS] and stable ABC, injured nearest to a NSAH were transported either to that hospital (control clusters) or bypassed to the nearest NC (intervention clusters). Primary outcomes: recruitment rate, protocol compliance, selection bias as a result of non-compliance, accuracy of paramedic TBI identification (overtriage of study inclusion criteria) and pathway acceptability to patients, families and staff. ‘Open-label’ secondary outcomes: 30-day mortality, 6-month Extended Glasgow Outcome Scale (GOSE) and European Quality of Life-5 Dimensions.ResultsOverall, 56 clusters recruited 293 (169 intervention, 124 control) patients in 12 months, demonstrating cluster randomised pre-hospital trials as viable for heath service evaluations. Overall compliance was 62%, but 90% was achieved in the control arm and when face-to-face paramedic training was possible. Non-compliance appeared to be driven by proximity of the nearest hospital and perceptions of injury severity and so occurred more frequently in the intervention arm, in which the perceived time to the NC was greater and severity of injury was lower. Fewer than 25% of recruited patients had TBI on computed tomography scan (n = 70), with 7% (n = 20) requiring neurosurgery (craniotomy, craniectomy or intracranial pressure monitoring) but a further 18 requiring admission to an intensive care unit. An intention-to-treat analysis revealed the two trial arms to be equivalent in terms of age, GCS and severity of injury. No significant 30-day mortality differences were found (8.8% vs. 9.1/%;p > 0.05) in the 273 (159/113) patients with data available. There were no apparent differences in staff and patient preferences for either pathway, with satisfaction high with both. Very low responses to invitations to consent for follow-up in the large number of mild head injury-enrolled patients meant that only 20% of patients had 6-month outcomes. The trial-based economic evaluation could not focus on early neurosurgery because of these low numbers but instead investigated the comparative cost-effectiveness of bypass compared with selective secondary transfer for eligible patients at the scene of injury.ConclusionsCurrent NHS England practice of bypassing patients with suspected TBI to neuroscience centres gives overtriage ratios of 13 : 1 for neurosurgery and 4 : 1 for TBI. This important finding makes studying the impact of bypass to facilitate early neurosurgery not plausible using this study design. Future research should explore an efficient comparative effectiveness design for evaluating ‘early neurosurgery through bypass’ and address the challenge of reliable TBI diagnosis at the scene of injury.Trial registrationCurrent Controlled Trials ISRCTN68087745.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 1. See the NIHR Journals Library website for further project information.

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Section: Resultsmentioning

confidence: 99%

“…Therefore, it is only relevant to those studies which aimed to recruit patients whose injuries could not be fully diagnosed in the pre-hospital environment. Woollard et al 134 Snooks et al 135 Mason et al…”

Section: Relevance Of Participants Recruitedmentioning

confidence: 99%

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

Lecky

Russell

Fuller

et al. 2016

Health Technol Assess

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“…A comparison of 5 mg and 10 mg nalbuphine doses given IV and repeated at 3-minute intervals to a total of 20 mg, showed that use of the larger dose led to better pain relief but higher patient-reported drowsiness; over half the patients in both groups still had significant pain on arrival at the hospital (Woollard et al, 2004 Level II).…”

Section: Chaptermentioning

confidence: 99%

“…As in other settings, pain intensity is best assessed using patient self-report measures such as VASs (Galinski et al, 2005;Kober et al, 2002), VNRSs (McLean et al, 2004;Woollard et al, 2004;Rickard et al, 2007;Bounes et al, 2008), VDSs (McLean et al, 2004;Vergnion et al, 2001), faces pain scales (Rogovik & Goldman, 2007) (see Section 2). A ruler incorporating both visual analogue and faces pain scales (Lord & Parsell, 2003 Level IV) has also been used to measure pain in patients prior to arrival at hospital.…”

Section: Assessment Of Pain In the Prehospital Environmentmentioning

confidence: 99%

Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non‐inferiority trial

Cohen

Smit

Andrianopoulos³

et al. 2017

Medical Journal of Australia

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Objectives: This study aimed to assess analgesia provided by acupuncture, alone or in combination with pharmacotherapy, to patients presenting to emergency departments with acute low back pain, migraine or ankle sprain. Design: A pragmatic, multicentre, randomised, assessor‐blinded, equivalence and non‐inferiority trial of analgesia, comparing acupuncture alone, acupuncture plus pharmacotherapy, and pharmacotherapy alone for alleviating pain in the emergency department. Setting, participants: Patients presenting to emergency departments in one of four tertiary hospitals in Melbourne with acute low back pain, migraine, or ankle sprain, and with a pain score on a 10‐point verbal numerical rating scale (VNRS) of at least 4. Main outcome measures: The primary outcome measure was pain at one hour (T1). Clinically relevant pain relief was defined as achieving a VNRS score below 4, and statistically relevant pain relief as a reduction in VNRS score of greater than 2 units. Results: 1964 patients were assessed between January 2010 and December 2011; 528 patients with acute low back pain (270 patients), migraine (92) or ankle sprain (166) were randomised to acupuncture alone (177 patients), acupuncture plus pharmacotherapy (178) or pharmacotherapy alone (173). Equivalence and non‐inferiority of treatment groups was found overall and for the low back pain and ankle sprain groups in both intention‐to‐treat and per protocol (PP) analyses, except in the PP equivalence testing of the ankle sprain group. 15.6% of patients had clinically relevant pain relief and 36.9% had statistically relevant pain relief at T1; there were no between‐group differences. Conclusion: The effectiveness of acupuncture in providing acute analgesia for patients with back pain and ankle sprain was comparable with that of pharmacotherapy. Acupuncture is a safe and acceptable form of analgesia, but none of the examined therapies provided optimal acute analgesia. More effective options are needed. Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12609000989246.

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“…The excluded analgesics were NSAIDs [ketorolac (Wright et al, 1994;Turturro et al, 1995;Neighbor and Puntillo, 1998;Rainer et al, 2000), mefenamic acid (Stableforth, 1977;Sleet and Khan, 1980), diflunisal (Aghababian, 1986) and piroxicam (Morán, 1990)], opioids [nalbuphine (Stene et al, 1988;Chambers and Guly, 1994;Hyland-McGuire and Guly, 1998;Woollard et al, 2002Woollard et al, , 2004, hydrocodone (Marco et al, 2005) and butorphanol (Scott et al, 1994)] and a type of paracetamol [hydrocodoneacetaminophen (Turturro et al, 1998)]. This may have led to the loss of relevant information for emergency care settings in other countries.…”

Section: Limitations In Literature Search and Analysismentioning

confidence: 99%

Review on pharmacological pain management in trauma patients in (pre‐hospital) emergency medicine in the Netherlands

Dijkstra

Berben

Dongen

et al. 2013

European Journal of Pain

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Pain is one of the main complaints of trauma patients in (pre-hospital) emergency medicine. Significant deficiencies in pain management in emergency medicine have been identified. No evidence-based protocols or guidelines have been developed so far, addressing effectiveness and safety issues, taking the specific circumstances of pain management of trauma patients in the chain of emergency care into account. The aim of this systematic review was to identify effective and safe initial pharmacological pain interventions, available in the Netherlands, for trauma patients with acute pain in the chain of emergency care. Up to December 2011, a systematic search strategy was performed with MeSH terms and free text words, using the bibliographic databases CINAHL, PubMed and Embase. Methodological quality of the articles was assessed using standardized evaluation forms. Of a total of 2328 studies, 25 relevant studies were identified. Paracetamol (both orally and intravenously) and intravenous opioids (morphine and fentanyl) proved to be effective. Non-steroidal anti-inflammatory drugs (NSAIDs) showed mixed results and are not recommended for use in pre-hospital ambulance or (helicopter) emergency medical services [(H)EMS]. These results could be used for the development of recommendations on evidence-based pharmacological pain management and an algorithm to support the provision of adequate (pre-hospital) pain management. Future studies should address analgesic effectiveness and safety of various drugs in (pre-hospital) emergency care. Furthermore, potential innovative routes of administration (e.g., intranasal opioids in adults) need further exploration.

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Less IS less: a randomised controlled trial comparing cautious and rapid nalbuphine dosing regimens

Cited by 13 publications

References 12 publications

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non‐inferiority trial

Review on pharmacological pain management in trauma patients in (pre‐hospital) emergency medicine in the Netherlands

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